GS-4000 REDUCER SLEEVE, 11MM TO 5MM

Cannula And Trocar, Suprapubic, Non-disposable

SOLOS ENDOSCOPY, INC.

The following data is part of a premarket notification filed by Solos Endoscopy, Inc. with the FDA for Gs-4000 Reducer Sleeve, 11mm To 5mm.

Pre-market Notification Details

Device IDK900955
510k NumberK900955
Device Name:GS-4000 REDUCER SLEEVE, 11MM TO 5MM
ClassificationCannula And Trocar, Suprapubic, Non-disposable
Applicant SOLOS ENDOSCOPY, INC. 6191 ATLANTIC BLVD. SUITE 4 Norcross,  GA  30071
ContactLeila H Holmes
CorrespondentLeila H Holmes
SOLOS ENDOSCOPY, INC. 6191 ATLANTIC BLVD. SUITE 4 Norcross,  GA  30071
Product CodeFBM  
CFR Regulation Number876.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-27
Decision Date1990-04-18

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