FDA 510(k) Application Details - K984448

Device Classification Name Expander, Surgical, Skin Graft

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510(K) Number K984448
Device Name Expander, Surgical, Skin Graft
Applicant WELLS JOHNSON CO.
8000 SOUTH KOLB RD.
TUCSON, AZ 85706 US
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Contact KEN RODENBURG
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Regulation Number 878.4800

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Classification Product Code FZW
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Date Received 12/14/1998
Decision Date 01/28/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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