FDA 510(k) Application Details - K030774

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K030774
Device Name Dressing, Wound, Collagen
Applicant SOUTHWEST TECHNOLOGIES, INC.
1746 LEVEE RD.
KANSAS CITY, MO 64116 US
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Contact EDWARD I STOUT
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 03/11/2003
Decision Date 08/09/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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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