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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, bone
510(k) Number K192655
Device Name Depuy Synthes Maxillofacial Portfolio - MR Conditional
Applicant
Synthes (USA) Products LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Satapa Dhamankar
Correspondent
Synthes (USA) Products LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Satapa Dhamankar
Regulation Number872.4760
Classification Product Code
JEY  
Date Received09/25/2019
Decision Date 12/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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