The following data is part of a premarket notification filed by Thermogenesis Corp. with the FDA for Cryoseal Fs Applicator System.
| Device ID | K071126 |
| 510k Number | K071126 |
| Device Name: | CRYOSEAL FS APPLICATOR SYSTEM |
| Classification | Syringe, Piston |
| Applicant | THERMOGENESIS CORP. 2711 CITRUS RD. Rancho Cordova, CA 95742 |
| Contact | John Chapman |
| Correspondent | John Chapman THERMOGENESIS CORP. 2711 CITRUS RD. Rancho Cordova, CA 95742 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-23 |
| Decision Date | 2007-08-16 |
| Summary: | summary |