SRI Healthcare, LLC

FDA Device Registration & Listing · ATL, GA, US · Registration 1055954

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1055954
FEI Number
1000113384
Entity Name
SRI Healthcare, LLC
City/State/Country
ATL, GA, US
Establishment Address
5155 WESTPARK DR SW, ATL, GA 30336, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
SRI Healthcare, LLC (Owner Number: 10054706)
Owner / Operator Contact Address
5155 Westpark Dr. SW, Atlanta, GA 30336, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Novo Health Services SRI Healthcare, LLC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2017-04-18

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
1065597 SRI Healthcare, LLC CHATTANOOGA, TN, US
1527607 SRI Healthcare, LLC MASON, OH, US
1055892 SRI Healthcare, LLC MEBANE, NC, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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 1055954. Last updated year: 2026. Please use registration number 1055954 when referencing this establishment in official correspondence.
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