FDA 510(k) Application Details - K971682

Device Classification Name Wire, Surgical

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510(K) Number K971682
Device Name Wire, Surgical
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM, MA 02767 US
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Contact JOHN FERROS
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Regulation Number 000.0000

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Classification Product Code LRN
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Date Received 05/06/1997
Decision Date 06/27/1997
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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