The following data is part of a premarket notification filed by Minnesota Laser Corp. with the FDA for Nd:yag Surgical Laser For Gastro/urology Applica..
| Device ID | K874253 |
| 510k Number | K874253 |
| Device Name: | ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. |
| Classification | Laser For Gastro-urology Use |
| Applicant | MINNESOTA LASER CORP. 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy MINNESOTA LASER CORP. 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-20 |
| Decision Date | 1988-07-12 |