PRESSURE RELIEF VALVE— 510(k) K941492

Name: FDA 510(k) clearance K941492
Creator: U.S. Food and Drug Administration
Published: 1994-10-26

Substantially Equivalent

Circulatory Technology, Inc.

FDA 510(k) clearance K941492 for PRESSURE RELIEF VALVE, Substantially Equivalent on 1994-10-26. Applicant: Circulatory Technology, Inc.. Device class: 2.

Clearance details

Applicant: Circulatory Technology, Inc.
Product code: Code MNJ
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1994-03-28
Decision date: 1994-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oyster Bay, NY, US

Download summary PDF View on FDA.gov ↗

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