Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005391805

FEI Number

3005391805

Entity Name

ATLANTA HEALTHCARE SERVICES

City/State/Country

Lawrenceville, GA, US

Establishment Address

414 S Perry St, Lawrenceville, GA 30046, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device

Owner / Operator

ATLANTA HEALTHCARE SERVICES (Owner Number: 9077141)

Owner / Operator Contact Address

414 S Perry St, --, Lawrenceville, GA 30046, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OcuDrape OcuPak OcuDrape Private Label OcuDrape OcuPak GUARDIAN OcuDrape Private Label Ophthalmic Wipe OcuPak OcuDrape OcuDrape Private Label OcuPak OcuPak OcuDrape Private Label

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERY	Drape, Surgical, Ent	General, Plastic Surgery	Class 2	878.4370	2018-12-21
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2015-05-28
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2005-09-06
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2012-01-27
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-12-07
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2005-09-06
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2012-01-27

Official Correspondent

CHARLES ATKINS, IV

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ATLANTA HEALTHCARE SERVICES

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08

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.

Similar Registrations

Registration Number	Establishment Name	Location
3030220356	SUZHOU SHANGCHUANG TECHNOLOGY SERVICE CO., LTD.	Suzhou Jiangsu, CN
3013500854	BETATEX S.P.A.	Ospedalicchio di Bastia Umbra Perugia, IT
1423537	Cardinal Health 200, LLC	Waukegan, IL, US
3016874083	HANH MINH MANUFACTURING TRADING COMPANY LIMITED	Bien Hoa Dong Nai, VN
3010160370	Hebei Ruinuo Medical Instrument Co Ltd	Shijiazhuang Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005391805. Last updated year: 2026. Please use registration number 3005391805 when referencing this establishment in official correspondence.