FDA 510(k) Application Details - K950272

Device Classification Name Staple, Fixation, Bone

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510(K) Number K950272
Device Name Staple, Fixation, Bone
Applicant ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE, NJ 08876-0151 US
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Contact JOHN D PAULSON
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Regulation Number 888.3030

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Classification Product Code JDR
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Date Received 01/23/1995
Decision Date 01/18/1996
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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