The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Harmonic Scalpel Blades And Shears.
| Device ID | K053056 |
| 510k Number | K053056 |
| Device Name: | HARMONIC SCALPEL BLADES AND SHEARS |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 |
| Contact | Elizabeth Miller |
| Correspondent | Elizabeth Miller ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 |
| 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 | 2005-10-31 |
| Decision Date | 2006-01-19 |
| Summary: | summary |