DEGANIA SILICONE IDENTI 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 Identi Loops.

Pre-market Notification Details

Device IDK981956
510k NumberK981956
Device Name:DEGANIA SILICONE IDENTI 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 Received1998-06-04
Decision Date1998-07-09
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.