The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Ultracision 5mm Instruments.
| Device ID | K983316 |
| 510k Number | K983316 |
| Device Name: | ULTRACISION 5MM INSTRUMENTS |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Chuck Tabri |
| Correspondent | Chuck Tabri ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| 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 | 1998-09-21 |
| Decision Date | 1998-10-21 |
| Summary: | summary |