The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan 4300 & 4310 Ultrasonic Surgical Apirators.
| Device ID | K883091 |
| 510k Number | K883091 |
| Device Name: | SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Contact | Stephen Dalton |
| Correspondent | Stephen Dalton SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| 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 | 1988-07-22 |
| Decision Date | 1988-10-14 |