Device Classification Name |
instrument, ultrasonic surgical
|
510(k) Number |
K101561 |
FOIA Releasable 510(k) |
K101561
|
Device Name |
TX1 TISSUE REMOVAL SYSTEM |
Applicant |
AMERICAN OPTISURGICAL, INC. |
25501 ARCTIC OCEAN |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
DAVID SALZBERG |
Correspondent |
AMERICAN OPTISURGICAL, INC. |
25501 ARCTIC OCEAN |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
DAVID SALZBERG |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/04/2010 |
Decision Date | 08/27/2010 |
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
|
|
|