FLOW CONTROL VALVE, CAT. NO. ACV-38— 510(k) K922356

Name: FDA 510(k) clearance K922356
Creator: U.S. Food and Drug Administration
Published: 1993-02-12

Substantially Equivalent

American Omni Medical, Inc.

FDA 510(k) clearance K922356 for FLOW CONTROL VALVE, CAT. NO. ACV-38, Substantially Equivalent on 1993-02-12. Applicant: American Omni Medical, Inc.. Device class: 2.

Clearance details

Applicant: American Omni Medical, Inc.
Product code: Code MJJ
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1992-05-19
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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