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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stimulator, Nerve
510(k) Number K880720
Device Name MONTGOMERY NERVE STIMULATOR
Applicant
Boston Medical Products, Inc.
87 Rumford Ave.
Waltham,  MA  02154
Applicant Contact STUART K MONTGOMERY
Correspondent
Boston Medical Products, Inc.
87 Rumford Ave.
Waltham,  MA  02154
Correspondent Contact STUART K MONTGOMERY
Regulation Number874.1820
Classification Product Code
ETN  
Date Received02/23/1988
Decision Date 05/20/1988
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
Predetermined Change
Control Plan Authorized
No
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