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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube tracheostomy and tube cuff
510(k) Number K955516
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 Number868.5800
Classification Product Code
JOH  
Date Received12/04/1995
Decision Date 12/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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