The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic Focus Curved Shears And Torque Wrench, Harmonic Blue Hand Piece And Test Tip.
| Device ID | K063192 |
| 510k Number | K063192 |
| Device Name: | HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Elizabeth Miller, Mst |
| Correspondent | Elizabeth Miller, Mst ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD 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 | 2006-10-20 |
| Decision Date | 2007-01-30 |
| Summary: | summary |