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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K000416
Device Name TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
Applicant
Retinalabs.Com
1776 Peachtree St.
200 N.
Atlanta,  GA  30309
Applicant Contact FRANK TIGHE
Correspondent
Retinalabs.Com
1776 Peachtree St.
200 N.
Atlanta,  GA  30309
Correspondent Contact FRANK TIGHE
Regulation Number876.1500
Classification Product Code
MPA  
Date Received02/08/2000
Decision Date 05/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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