Cleared Traditional

COLLAGEN SHIELD FOR ACUTE CARE

K913148 · Vitaphore Corp. · Ophthalmic
Oct 1991
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K913148 is an FDA 510(k) clearance for the COLLAGEN SHIELD FOR ACUTE CARE, a Collagen Corneal Shield (Class I — General Controls, product code MOE), submitted by Vitaphore Corp. (Menlo Park, US). The FDA issued a Cleared decision on October 15, 1991, 91 days after receiving the submission on July 16, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4750.

Submission Details

510(k) Number K913148 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1991
Decision Date October 15, 1991
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MOE — Collagen Corneal Shield
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4750

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