The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Model 2100 Nd:yag Surgical Laser Gynecological Use.
| Device ID | K871579 |
| 510k Number | K871579 |
| Device Name: | MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE |
| Classification | Laser, Surgical, Gynecologic |
| 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 | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-23 |
| Decision Date | 1987-11-16 |