The following data is part of a premarket notification filed by Cryodyne Technologies, Inc. with the FDA for L.c.s.3000.
| Device ID | K926464 |
| 510k Number | K926464 |
| Device Name: | L.C.S.3000 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CRYODYNE TECHNOLOGIES, INC. C/O STIEFEL LABORATORIES, INC. Oak Hill, NY 12460 |
| Contact | William A Carr |
| Correspondent | William A Carr CRYODYNE TECHNOLOGIES, INC. C/O STIEFEL LABORATORIES, 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 | 1992-12-24 |
| Decision Date | 1993-08-24 |