OPTICAL VALVULOTOME— 510(k) K914385

Name: FDA 510(k) clearance K914385
Creator: U.S. Food and Drug Administration
Published: 1992-03-02

Substantially Equivalent

Intramed Laboratories, Inc.

FDA 510(k) clearance K914385 for OPTICAL VALVULOTOME, Substantially Equivalent on 1992-03-02. Applicant: Intramed Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Intramed Laboratories, Inc.
Product code: Code MGZ
Device class: Class 2
Regulation: 21 CFR 870.4885
Advisory panel: Cardiovascular
Date received: 1991-10-01
Decision date: 1992-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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