FDA 510(k) Application Details - K051181

Device Classification Name Plate, Fixation, Bone

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510(K) Number K051181
Device Name Plate, Fixation, Bone
Applicant ORTHOPEDIC SCIENCES, INC
3020 OLD RANCH PARKWAY
SUITE 325
SEAL BEACH, CA 90740 US
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Contact JAMES K BRANNON
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 05/09/2005
Decision Date 05/23/2005
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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