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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Vocal Cord Medialization
510(k) Number K972317
Device Name MONTGOMERY THYROPLASTY IMPLANT SYSTEM
Applicant
Boston Medical Products, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
Boston Medical Products, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number874.3620
Classification Product Code
MIX  
Date Received06/20/1997
Decision Date 09/18/1997
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
Predetermined Change
Control Plan Authorized		 No
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