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FDA 510(k) Application Details - K981526
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K981526
Device Name
Plate, Bone
Applicant
ACE SURGICAL SUPPLY CO., INC.
1034 PEARL ST.
BROCKTON, MA 02301 US
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Contact
EDWARD J CARCHIDI
Other 510(k) Applications for this Contact
Regulation Number
872.4760
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Classification Product Code
JEY
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More FDA Info for this Product Code
Date Received
04/28/1998
Decision Date
11/06/1998
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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