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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, ultrasonic surgical
510(k) Number K062544
Device Name AR1000 ULTRASONIC WOUND THERAPY SYSTEM
Applicant
AROBELLA MEDICAL, LLC
11460 N. MERIDIAN STREET
SUITE 150
CARMEL,  IN  46032
Applicant Contact Allison Scott
Correspondent
AROBELLA MEDICAL, LLC
11460 N. MERIDIAN STREET
SUITE 150
CARMEL,  IN  46032
Correspondent Contact Allison Scott
Classification Product Code
LFL  
Date Received08/30/2006
Decision Date 01/03/2007
Decision Substantially Equivalent (SESE)
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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