DEGANIA SILICONE INDENTI LOOPS

Clamp, Vascular

DEGANIA SILICONE, LTD.

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

Pre-market Notification Details

Device IDK964547
510k NumberK964547
Device Name:DEGANIA SILICONE INDENTI LOOPS
ClassificationClamp, Vascular
Applicant DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden,  IL 15130
ContactBette Lubin
CorrespondentBette Lubin
DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden,  IL 15130
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-13
Decision Date1997-01-08
Summary:summary

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