The following data is part of a premarket notification filed by Influence, Inc. with the FDA for Cryo-mono Cryogrnic System.
| Device ID | K991122 |
| 510k Number | K991122 |
| Device Name: | CRYO-MONO CRYOGRNIC SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | INFLUENCE, INC. 71 STEVENSON ST., SUITE 1120 San Francisco, CA 94105 |
| Contact | Peter M Bick |
| Correspondent | Peter M Bick INFLUENCE, INC. 71 STEVENSON ST., SUITE 1120 San Francisco, CA 94105 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-02 |
| Decision Date | 1999-07-01 |
| Summary: | summary |