Cleared Traditional

IDENTI LOOPS DEGANIA SILICONE

K920104 · Puritas Health Care, Inc. · Cardiovascular
Apr 1992
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K920104 is an FDA 510(k) clearance for the IDENTI LOOPS DEGANIA SILICONE, a Clip, Vascular (Class II — Special Controls, product code DSS), submitted by Puritas Health Care, Inc. (Brookfield, US). The FDA issued a Cleared decision on April 20, 1992, 102 days after receiving the submission on January 9, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3250.

Submission Details

510(k) Number K920104 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 1992
Decision Date April 20, 1992
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSS — Clip, Vascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3250

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