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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 K973018
Device Name SYNTHES MINI LENGTHENING APPARATUS
Applicant
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301 -1222
Applicant Contact SHERI L MUSGNUNG
Correspondent
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301 -1222
Correspondent Contact SHERI L MUSGNUNG
Regulation Number872.4760
Classification Product Code
MQN  
Date Received08/13/1997
Decision Date 11/10/1997
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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