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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K955634
Device Name MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
Applicant
BOSTON MEDICAL PRODUCTS, INC.
117 FLANDERS RD.
WESTBOROUGH,  MA  01581
Applicant Contact STUART K MONTGOMERY
Correspondent
BOSTON MEDICAL PRODUCTS, INC.
117 FLANDERS RD.
WESTBOROUGH,  MA  01581
Correspondent Contact STUART K MONTGOMERY
Regulation Number868.5870
Classification Product Code
CBP  
Date Received12/11/1995
Decision Date 06/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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