Cleared Traditional

K944872 - BIO-COR COLLAGEN CORNEAL SHIELD
(FDA 510(k) Clearance)

K944872 · Bausch & Lomb Healthcare and Optics Worldwide · Ophthalmic

Jul 1995

Decision

296d

Days

Class 1

Risk

K944872 is an FDA 510(k) clearance for the BIO-COR COLLAGEN CORNEAL SHIELD, a Collagen Corneal Shield (Class I — General Controls, product code MOE), submitted by Bausch & Lomb Healthcare and Optics Worldwide (Tampa, US). The FDA issued a Cleared decision on July 26, 1995, 296 days after receiving the submission on October 3, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4750.

Submission Details

510(k) Number	K944872 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 03, 1994
Decision Date	July 26, 1995
Days to Decision	296 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF