The following data is part of a premarket notification filed by Aomori Olympus Co., Ltd. with the FDA for Sonosurg Trocar.
| Device ID | K042160 |
| 510k Number | K042160 |
| Device Name: | SONOSURG TROCAR |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Tina Steffanie-oak |
| Correspondent | Tina Steffanie-oak AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-10 |
| Decision Date | 2005-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170208482 | K042160 | 000 |