The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Model 4060 N Nd:yag Laser For Urological Use.
| Device ID | K880193 |
| 510k Number | K880193 |
| Device Name: | MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE |
| Classification | Laser For Gastro-urology Use |
| 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 | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-19 |
| Decision Date | 1988-04-14 |