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FDA 510(k) Application Details - K961094
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K961094
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
MITEK PRODUCTS
60 GLACIER DR.
WESTWOOD, MA 02090 US
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Contact
EDWARD F KENT
Other 510(k) Applications for this Contact
Regulation Number
888.3040
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Classification Product Code
MBI
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More FDA Info for this Product Code
Date Received
03/14/1996
Decision Date
10/03/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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