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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, larynx (stents and keels)
510(k) Number K962693
Device Name MONTGOMERY RADIOPAQUE LARYNGEAL KEEL
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 Number874.3620
Classification Product Code
FWN  
Date Received07/11/1996
Decision Date 08/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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