FDA 510(k) Application Details - K021749

Device Classification Name Plate, Fixation, Bone, Non-Spinal, Metallic

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510(K) Number K021749
Device Name Plate, Fixation, Bone, Non-Spinal, Metallic
Applicant EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY, NJ 07054 US
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Contact JON CAPARETTA
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Regulation Number 888.3030

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Classification Product Code NDF
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Date Received 05/28/2002
Decision Date 08/12/2002
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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