Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1527607

FEI Number

1527607

Entity Name

SRI Healthcare, LLC

City/State/Country

MASON, OH, US

Establishment Address

7086 INDUSTRIAL ROW RD., MASON, OH 45040, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SRI Healthcare, LLC (Owner Number: 10054706)

Owner / Operator Contact Address

5155 Westpark Dr. SW, Atlanta, GA 30336, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K041541

PMA Number

N/A

All Registered Proprietary Names

SRI Healthcare, LLC Novo Health Services Novo Health Services SRI Healthcare, LLC SRI Healthcare, LLC Novo Health Services Novo Health Services SRI Healthcare, LLC SRI Healthcare, LLC Novo Health Services Novo Health Services SRI Healthcare, LLC Novo Health Services SRI Healthcare, LLC SRI Healthcare, LLC Novo Health Services Novo Health Services SRI Healthcare SRI Healthcare, LLC Novo Health Services Novo Health Services SRI Healthcare, LLC Novo Health Services SRI Healthcare, LLC Novo Health Services SRI Healthcare, LLC Novo Health Services SRI Healthcare, LLC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-08-30
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-05
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2018-08-30
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2017-04-17
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2018-08-30
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-09-05
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2018-09-05
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2017-04-18
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-05
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-08-03
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-08-30
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2020-03-05
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2021-04-13
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2017-04-17
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-01-28

Official Correspondent

Rebecca Cox

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SRI Healthcare, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1055954	SRI Healthcare, LLC	ATL, GA, US
1065597	SRI Healthcare, LLC	CHATTANOOGA, TN, US
1055892	SRI Healthcare, LLC	MEBANE, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1527607. Last updated year: 2026. Please use registration number 1527607 when referencing this establishment in official correspondence.