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FDA 510(k) Application Details - K952847
Device Classification Name
External Mandibular Fixator And/Or Distractor
More FDA Info for this Device
510(K) Number
K952847
Device Name
External Mandibular Fixator And/Or Distractor
Applicant
ACE SURGICAL SUPPLY CO., INC.
1034 PEARL ST.
P.O. BOX 1710
BROCKTON, MA 02403 US
Other 510(k) Applications for this Company
Contact
J. EDWARD CARCHIDI
Other 510(k) Applications for this Contact
Regulation Number
872.4760
More FDA Info for this Regulation Number
Classification Product Code
MQN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/21/1995
Decision Date
02/06/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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