The following data is part of a premarket notification filed by Influence, Inc. with the FDA for Cryo-mono Cryogenic System, Model Cryo-mono With Tuf Probe.
| Device ID | K991792 |
| 510k Number | K991792 |
| Device Name: | CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-26 |
| Decision Date | 1999-08-12 |
| Summary: | summary |