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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pick, Massaging
510(k) Number K911418
Device Name GUM MASSAGER
Applicant
Burn-Henderson Partnership
10 S. Potomac
Suite B
Aurora,  CO  80012
Applicant Contact CHESTER A BURN
Correspondent
Burn-Henderson Partnership
10 S. Potomac
Suite B
Aurora,  CO  80012
Correspondent Contact CHESTER A BURN
Regulation Number872.6650
Classification Product Code
JET  
Date Received04/01/1991
Decision Date 07/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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