The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray.
| Device ID | K211273 |
| 510k Number | K211273 |
| Device Name: | Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 |
| Contact | Nathan Anderson |
| Correspondent | Ruth James Ethicon Endo-Surgery, Inc. 4545 Creek Road Blue Ash, OH 45242 |
| 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 | 2021-04-27 |
| Decision Date | 2021-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705036023443 | K211273 | 000 |
| 30705036023429 | K211273 | 000 |