MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR— 510(k) K851152

Name: FDA 510(k) clearance K851152
Creator: U.S. Food and Drug Administration
Published: 1985-06-24

Substantially Equivalent

Cryomedics, Inc.

FDA 510(k) clearance K851152 for MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR, Substantially Equivalent on 1985-06-24. Applicant: Cryomedics, Inc.. Device class: 1.

Clearance details

Applicant: Cryomedics, Inc.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1985-03-21
Decision date: 1985-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, CT, US

Download summary PDF View on FDA.gov ↗

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