FDA 510(k) Application Details - K982719

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K982719
Device Name Pin, Fixation, Smooth
Applicant SURGICRAFT LTD.
FISHING LINE RD.
REDDITCH, WORCS. B97 6HF GB
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Contact SIMON FITZER
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 08/04/1998
Decision Date 09/25/1998
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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