The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Instrument, Ultrasonic, Scalpel.
| Device ID | K990362 |
| 510k Number | K990362 |
| Device Name: | INSTRUMENT, ULTRASONIC, SCALPEL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Ruth Ann Wood |
| Correspondent | Ruth Ann Wood ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-05 |
| Decision Date | 1999-09-17 |
| Summary: | summary |