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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K954471
Device Name POWERS ANTI-BACTERIAL VALVE
Applicant
Powers Dental & Medical Technology, Inc.
1855 Waldorf NW
Grand Rapids,  MI  49544
Applicant Contact SUSAN NEUMAN
Correspondent
Powers Dental & Medical Technology, Inc.
1855 Waldorf NW
Grand Rapids,  MI  49544
Correspondent Contact SUSAN NEUMAN
Regulation Number872.6640
Classification Product Code
EIA  
Date Received09/26/1995
Decision Date 04/15/1996
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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