FDA 510(k) Application Details - K963937

Device Classification Name Screw, Fixation, Bone

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510(K) Number K963937
Device Name Screw, Fixation, Bone
Applicant NORTHWEST PRECISION TECHNOLOGIES
812 WEST 8TH ST.
SUITE 8144
THE DALLES, OR 97058 US
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Contact DAVE STINSON
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 10/01/1996
Decision Date 01/22/1997
Decision SN - Substantially Equivalent for Some Indications
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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