FDA 510(k) Application Details - K970439

Device Classification Name System, Skin Closure

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510(K) Number K970439
Device Name System, Skin Closure
Applicant PROGRESSIVE SURGICAL PRODUCTS, INC.
694 MAIN ST.
WESTBURY, NY 11590 US
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Contact ROBERT ODDSON
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Regulation Number 878.4320

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Classification Product Code MKY
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Date Received 02/05/1997
Decision Date 04/16/1997
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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