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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Distraction System
510(k) Number K170818
Device Name Craniomaxillofacial Distraction System (CMFD)
Applicant
Synthes USA Products, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Nicholas Fountoulakis
Correspondent
Synthes USA Products, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Nicholas Fountoulakis
Regulation Number882.5330
Classification Product Code
PBJ  
Date Received03/20/2017
Decision Date 12/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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