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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K080682
Device Name HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE
Applicant
Handpiece Headquarters, Inc. - Hpr, Inc.
2284 N. Glassell St., Unit A
Orange,  CA  92865
Applicant Contact TINA STEFFANIE-OAK
Correspondent
Handpiece Headquarters, Inc. - Hpr, Inc.
2284 N. Glassell St., Unit A
Orange,  CA  92865
Correspondent Contact TINA STEFFANIE-OAK
Regulation Number872.4200
Classification Product Code
EFB  
Date Received03/10/2008
Decision Date 09/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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