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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula and trocar, suprapubic, non-disposable
510(k) Number K900955
Device Name GS-4000 REDUCER SLEEVE, 11MM TO 5MM
Applicant
SOLOS ENDOSCOPY, INC.
6191 ATLANTIC BLVD. SUITE 4
NORCROSS,  GA  30071
Applicant Contact LEILA H HOLMES
Correspondent
SOLOS ENDOSCOPY, INC.
6191 ATLANTIC BLVD. SUITE 4
NORCROSS,  GA  30071
Correspondent Contact LEILA H HOLMES
Regulation Number876.5090
Classification Product Code
FBM  
Date Received02/27/1990
Decision Date 04/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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