DYNABITE CARDIOVASCULAR BIOPSY FORCEPS— 510(k) K951447

Name: FDA 510(k) clearance K951447
Creator: U.S. Food and Drug Administration
Published: 1995-07-27

Substantially Equivalent

Portlyn Corp.

FDA 510(k) clearance K951447 for DYNABITE CARDIOVASCULAR BIOPSY FORCEPS, Substantially Equivalent on 1995-07-27. Applicant: Portlyn Corp.. Device class: 2.

Clearance details

Applicant: Portlyn Corp.
Product code: Code DWZ
Device class: Class 2
Regulation: 21 CFR 870.4075
Advisory panel: Cardiovascular
Date received: 1995-03-29
Decision date: 1995-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moultonboro, NH, US

Download summary PDF View on FDA.gov ↗

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