FDA 510(k) Application Details - K040250

Device Classification Name Washer, Bolt Nut

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510(K) Number K040250
Device Name Washer, Bolt Nut
Applicant TRIAGE MEDICAL INC
13700 ALTON PKWY.
SUITE 160
IRVINE, CA 92618 US
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Contact GAYLE HIROTA
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Regulation Number 888.3030

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Classification Product Code HTN
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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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