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FDA 510(k) Application Details - K040250
Device Classification Name
Washer, Bolt Nut
More FDA Info for this Device
510(K) Number
K040250
Device Name
Washer, Bolt Nut
Applicant
TRIAGE MEDICAL INC
13700 ALTON PKWY.
SUITE 160
IRVINE, CA 92618 US
Other 510(k) Applications for this Company
Contact
GAYLE HIROTA
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HTN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/02/2004
Decision Date
03/23/2004
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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