Device Classification Name |
instrument, ultrasonic surgical
|
510(k) Number |
K172691 |
Device Name |
Ultrasonic Generator |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORP. |
2951 Ishikawa-cho |
Hachioji-shi,
JP
192-8507
|
|
Applicant Contact |
Toshiyuki Nakajima |
Correspondent |
Gyrus ACMI, Inc. |
136 Turnpike Road |
Southborough,
MA
01772
|
|
Correspondent Contact |
Graham A.L. Baillie |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/06/2017 |
Decision Date | 10/04/2017 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|