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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 K952847
Device Name NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
Applicant
ACE SURGICAL SUPPLY CO., INC.
1034 PEARL ST.
P.O. BOX 1710
BROCKTON,  MA  02403
Applicant Contact J. EDWARD CARCHIDI
Correspondent
ACE SURGICAL SUPPLY CO., INC.
1034 PEARL ST.
P.O. BOX 1710
BROCKTON,  MA  02403
Correspondent Contact J. EDWARD CARCHIDI
Regulation Number872.4760
Classification Product Code
MQN  
Date Received06/21/1995
Decision Date 02/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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