MONTGOMERY TRACHEOSTOMY SPEAKING VALVE— 510(k) K955634

Name: FDA 510(k) clearance K955634
Creator: U.S. Food and Drug Administration
Published: 1996-06-10

Substantially Equivalent

Boston Medical Products, Inc.

FDA 510(k) clearance K955634 for MONTGOMERY TRACHEOSTOMY SPEAKING VALVE, Substantially Equivalent on 1996-06-10. Applicant: Boston Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Boston Medical Products, Inc.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 1995-12-11
Decision date: 1996-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westborough, MA, US

Download summary PDF View on FDA.gov ↗

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