The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Ultrasonic Generator.
| Device ID | K172691 |
| 510k Number | K172691 |
| Device Name: | Ultrasonic Generator |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Graham A.l. Baillie Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-06 |
| Decision Date | 2017-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170386817 | K172691 | 000 |
| 14953170306751 | K172691 | 000 |
| 14953170306744 | K172691 | 000 |