FDA 510(k) Application Details - K770128

Device Classification Name Plate, Fixation, Bone

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510(K) Number K770128
Device Name Plate, Fixation, Bone
Applicant HOWMEDICA CORP.

, US
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 01/21/1977
Decision Date 01/26/1977
Decision SE - Substantially Equivalent
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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