The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cryosurgical Device 2000.
| Device ID | K781956 |
| 510k Number | K781956 |
| Device Name: | CRYOSURGICAL DEVICE 2000 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | VALLEYLAB, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-21 |
| Decision Date | 1979-01-10 |