Cleared Traditional

SLIMCATH (TM)

K903001 · Gynopharma, Inc. · Ophthalmic
Jun 1991
Decision
351d
Days
Class 1
Risk

About This 510(k) Submission

K903001 is an FDA 510(k) clearance for the SLIMCATH (TM), a Tester, Color Vision (Class I — General Controls, product code HIT), submitted by Gynopharma, Inc. (Princeton, US). The FDA issued a Cleared decision on June 25, 1991, 351 days after receiving the submission on July 9, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1170.

Submission Details

510(k) Number K903001 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 1990
Decision Date June 25, 1991
Days to Decision 351 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HIT — Tester, Color Vision
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1170

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