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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K240321
Device Name MP Pin flat without thread (36BMP000020/MP20)
Applicant
Hager& Meisinger GmbH
Hansemannstr. 10
Neuss,  DE 41468
Applicant Contact Melanie Otto
Correspondent
Hager& Meisinger GmbH
Hansemannstr. 10
Neuss,  DE 41468
Correspondent Contact Melanie Otto
Regulation Number872.4880
Classification Product Code
DZL  
Date Received02/02/2024
Decision Date 10/17/2024
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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