FDA 510(k) Application Details - K990530

Device Classification Name Dressing,Wound,Occlusive

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510(K) Number K990530
Device Name Dressing,Wound,Occlusive
Applicant THE KENDALL COMPANY, L.P.
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
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Contact DAVID A OLSON
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Regulation Number 878.4020

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Classification Product Code NAD
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Date Received 02/19/1999
Decision Date 01/31/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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