IDENTI LOOPS DEGANIA SILICONE

Clip, Vascular

PURITAS HEALTH CARE, INC.

The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Identi Loops Degania Silicone.

Pre-market Notification Details

Device IDK920104
510k NumberK920104
Device Name:IDENTI LOOPS DEGANIA SILICONE
ClassificationClip, Vascular
Applicant PURITAS HEALTH CARE, INC. 76 STONY HILL VILLAGE Brookfield,  CT  06804
ContactArcovio, Jr.
CorrespondentArcovio, Jr.
PURITAS HEALTH CARE, INC. 76 STONY HILL VILLAGE Brookfield,  CT  06804
Product CodeDSS  
CFR Regulation Number870.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-09
Decision Date1992-04-20

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