The following data is part of a premarket notification filed by Surgilase, Inc. with the FDA for Nd:yag 100 Surgical Laser For Gastro. And Urology.
| Device ID | K875039 |
| 510k Number | K875039 |
| Device Name: | ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY |
| Classification | Laser For Gastro-urology Use |
| Applicant | SURGILASE, INC. I-95 CORPORATE PARK 33 PLAN WAY Warwick, RI 02866 |
| Contact | Timothy J Shea |
| Correspondent | Timothy J Shea SURGILASE, INC. I-95 CORPORATE PARK 33 PLAN WAY Warwick, RI 02866 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-07 |
| Decision Date | 1988-04-13 |