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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name negative pressure wound therapy powered suction pump
510(k) Number K100823
Device Name WOUND PRO APEX
Applicant
ACCURO MEDICAL PRODUCTS LLC
3879 east 120th ave
suite 328
denver,  CO  80233
Applicant Contact todd hubbard
Correspondent
ACCURO MEDICAL PRODUCTS LLC
3879 east 120th ave
suite 328
denver,  CO  80233
Correspodent Contact todd hubbard
Regulation Number878.4780
Classification Product Code
OMP  
Date Received03/24/2010
Decision Date 01/24/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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