FDA 510(k) Application Details - K991873

Device Classification Name Plate, Fixation, Bone

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510(K) Number K991873
Device Name Plate, Fixation, Bone
Applicant KINETIKOS MEDICAL, INC.
4115 SORRENTO VALLEY BLVD.
SAN DIEGO, CA 92121 US
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Contact MICHAEL COLLINS
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 06/02/1999
Decision Date 08/17/1999
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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