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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K141125
Device Name U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE
Applicant
Handpiece Headquarters
620 S. Placentia Ave.
Placentia,  CA  92870
Applicant Contact TINA STEFFANIE-OAK
Correspondent
Handpiece Headquarters
620 S. Placentia Ave.
Placentia,  CA  92870
Correspondent Contact TINA STEFFANIE-OAK
Regulation Number872.4200
Classification Product Code
EGS  
Date Received05/01/2014
Decision Date 10/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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