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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Cleaner, Ultrasound
510(k) Number K091038
Device Name AS 1000 ULTRASOUND WOUND THERAPY SYSTEM
Applicant
Arobella Medical, LLC
5929 Baker Rd.
Suite 470
Minnetonka,  MN  55345
Applicant Contact ELIAZ BABAEV
Correspondent
Arobella Medical, LLC
5929 Baker Rd.
Suite 470
Minnetonka,  MN  55345
Correspondent Contact ELIAZ BABAEV
Regulation Number878.4410
Classification Product Code
NRB  
Subsequent Product Code
FQH  
Date Received04/13/2009
Decision Date 06/19/2009
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
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