DEGANIA SILICONE TOURNIQUET

Tourniquet, Nonpneumatic

DEGANIA SILICONE, LTD.

The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Degania Silicone Tourniquet.

Pre-market Notification Details

Device IDK875092
510k NumberK875092
Device Name:DEGANIA SILICONE TOURNIQUET
ClassificationTourniquet, Nonpneumatic
Applicant DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden,  IL 15130
ContactBette Lubin
CorrespondentBette Lubin
DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden,  IL 15130
Product CodeGAX  
CFR Regulation Number878.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-10
Decision Date1988-01-07

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