OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP— 510(k) K973552

Name: FDA 510(k) clearance K973552
Creator: U.S. Food and Drug Administration
Published: 1997-12-16

Substantially Equivalent

Bio-Vascular, Inc.

FDA 510(k) clearance K973552 for OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP, Substantially Equivalent on 1997-12-16. Applicant: Bio-Vascular, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Vascular, Inc.
Product code: Code MTZ
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 1997-09-19
Decision date: 1997-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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