FDA 510(k) Application Details - K970258

Device Classification Name Plate, Fixation, Bone

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510(K) Number K970258
Device Name Plate, Fixation, Bone
Applicant FERGUSON MEDICAL
3407 BAY AVE.
CHICO, CA 95973-8619 US
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Contact FRANK FERGUSON
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 01/23/1997
Decision Date 05/22/1997
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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