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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 K043555
FOIA Releasable 510(k) K043555
Device Name SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
Applicant
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301 -1222
Applicant Contact KATHY ANDERSON
Correspondent
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301 -1222
Correspondent Contact KATHY ANDERSON
Regulation Number872.4760
Classification Product Code
MQN  
Date Received12/27/2004
Decision Date 04/12/2005
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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