The following data is part of a premarket notification filed by Stiefel Research Institute, Inc. with the FDA for L.c.s. 2000 System.
| Device ID | K914591 |
| 510k Number | K914591 |
| Device Name: | L.C.S. 2000 SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | STIEFEL RESEARCH INSTITUTE, INC. Oak Hill, NY 12460 |
| Contact | Carr, Jr. |
| Correspondent | Carr, Jr. STIEFEL RESEARCH INSTITUTE, INC. Oak Hill, NY 12460 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-16 |
| Decision Date | 1992-01-14 |