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FDA 510(k) Application Details - K022207
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K022207
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
AXYA MEDICAL, INC.
100 CUMMINGS CENTER
SUITE 444C
BEVERLY, MA 01915 US
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Contact
HOWARD L SCHRAYER
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/08/2002
Decision Date
10/04/2002
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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