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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Intranasal Septal
510(k) Number K972151
Device Name DOYLE COMBO NASAL AIRWAY SPLINT
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 Number874.4780
Classification Product Code
LYA  
Date Received06/09/1997
Decision Date 07/07/1997
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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