The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Sonosurg System.
| Device ID | K032066 |
| 510k Number | K032066 |
| Device Name: | SONOSURG SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
| Contact | Tina Steffanie-oak |
| Correspondent | Tina Steffanie-oak THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE 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 | 2003-07-03 |
| Decision Date | 2003-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170183215 | K032066 | 000 |
| 14953170183154 | K032066 | 000 |
| 14953170183147 | K032066 | 000 |
| 14953170183130 | K032066 | 000 |
| 14953170183000 | K032066 | 000 |
| 14953170182997 | K032066 | 000 |