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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 K042134
Device Name VERSATILE 1 WOUND VACUUM SYSTEM
Applicant
BLUE SKY MEDICAL GROUP INCORPORATED
1485 POINSETTIA AVE., STE 118
VISTA,  CA  92083
Applicant Contact RICHARD WESTON
Correspondent
BLUE SKY MEDICAL GROUP INCORPORATED
1485 POINSETTIA AVE., STE 118
VISTA,  CA  92083
Correspondent Contact RICHARD WESTON
Regulation Number878.4780
Classification Product Code
OMP  
Date Received08/09/2004
Decision Date 11/01/2004
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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