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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name trephine, sinus
510(k) Number K802915
Device Name MONTG. TRACHEAL TREPHINE FENE STRATOR
Applicant
BOSTON MEDICAL PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BOSTON MEDICAL PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.4420
Classification Product Code
KBF  
Date Received11/19/1980
Decision Date 12/19/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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