SUTURE HANDLER

Laparoscope, General & Plastic Surgery

SURGIN SURGICAL INSTRUMENTATION, INC.

The following data is part of a premarket notification filed by Surgin Surgical Instrumentation, Inc. with the FDA for Suture Handler.

Pre-market Notification Details

Device IDK934173
510k NumberK934173
Device Name:SUTURE HANDLER
ClassificationLaparoscope, General & Plastic Surgery
Applicant SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin,  CA  92680
ContactDon W Haar
CorrespondentDon W Haar
SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin,  CA  92680
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-26
Decision Date1993-12-01

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