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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Button, Nasal Septal
510(k) Number K972060
Device Name NASAL SEPTAL BUTTON
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
Classification Product Code
LFB  
Date Received06/02/1997
Decision Date 07/03/1997
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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