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FDA 510(k) Application Details - K042796
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K042796
Device Name
Screw, Fixation, Bone
Applicant
COAPT SYSTEMS, INC.
1820 EMBARCADERO RD.
PALO ALTO, CA 94566 US
Other 510(k) Applications for this Company
Contact
BANKIM MEHTA
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/07/2004
Decision Date
11/05/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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