FDA 510(k) Application Details - K020077

Device Classification Name Dressing,Wound And Burn,Occlusive,Heated

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510(K) Number K020077
Device Name Dressing,Wound And Burn,Occlusive,Heated
Applicant AUGUSTINE MEDICAL, INC.
10393 WEST 70TH ST.
EDEN PRAIRIE, MN 55344 US
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Contact SCOTT D AUGUSTINE
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Regulation Number 000.0000

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Classification Product Code MSA
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Date Received 01/09/2002
Decision Date 01/31/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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