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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 K111532
Device Name MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE
Applicant
Anthogyr Sas
2237 Ave. Andre Lasquin
Sallanches,  FR 74700
Applicant Contact BRAYETTE SABINE
Correspondent
Anthogyr Sas
2237 Ave. Andre Lasquin
Sallanches,  FR 74700
Correspondent Contact BRAYETTE SABINE
Regulation Number872.4200
Classification Product Code
EGS  
Date Received06/03/2011
Decision Date 10/07/2011
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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