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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 K942480
Device Name M4 CONTRA-ANGLE HANDPIECE
Applicant
Kerr Corporation (Danbury)
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Applicant Contact JEFFREY A ANDERSON
Correspondent
Kerr Corporation (Danbury)
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Correspondent Contact JEFFREY A ANDERSON
Regulation Number872.4200
Classification Product Code
EGS  
Date Received05/25/1994
Decision Date 01/27/1995
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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