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 |
|
Date Received | 08/30/2006 |
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
|
|
|