HYLASHIELD CL— 510(k) K994170

Substantially Equivalent

Biomatrix, Inc.

FDA 510(k) clearance K994170 for HYLASHIELD CL, Substantially Equivalent on 2000-03-02. Applicant: Biomatrix, Inc.. Device class: 2.

Clearance details

Applicant: Biomatrix, Inc.
Product code: Code MRC
Device class: Class 2
Regulation: 21 CFR 886.5918
Advisory panel: Ophthalmic
Date received: 1999-12-10
Decision date: 2000-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridgefield, NJ, US

Download summary PDF View on FDA.gov ↗

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