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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 K061919
Device Name VERSATILE 1 EZCARE WOUND VACUUM SYSTEM
Applicant
Blue Sky Medical Group Incorporated
5924 Balfour Ct.
Suite 102
Carlsbad,  CA  92008
Applicant Contact JASPER BENKE
Correspondent
Blue Sky Medical Group Incorporated
5924 Balfour Ct.
Suite 102
Carlsbad,  CA  92008
Correspondent Contact JASPER BENKE
Regulation Number878.4780
Classification Product Code
OMP  
Date Received07/06/2006
Decision Date 02/05/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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