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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Mandibular Fixator And/Or Distractor
510(k) Number K181504
Device Name Stryker Pediatric Mandibular Distractor 2
Applicant
Stryker
750 Trade Centre Way -Suite 200
Portage,  MI  49002
Applicant Contact Gregory Gohl
Correspondent
Stryker
750 Trade Centre Way -Suite 200
Portage,  MI  49002
Correspondent Contact Gregory Gohl
Regulation Number872.4760
Classification Product Code
MQN  
Date Received06/07/2018
Decision Date 09/11/2018
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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