The following data is part of a premarket notification filed by Thermogenesis Corp. with the FDA for Thermogenesis Drop Applicator, Kits, Spray Kits And Tips.
| Device ID | K955282 |
| 510k Number | K955282 |
| Device Name: | THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS |
| Classification | Syringe, Piston |
| Applicant | THERMOGENESIS CORP. 11431 SUNRISE GOLD CIRCLE SUITE A Rancho Cordova, CA 95742 |
| Contact | Philip Coelho |
| Correspondent | Philip Coelho THERMOGENESIS CORP. 11431 SUNRISE GOLD CIRCLE SUITE A 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 | 1995-11-16 |
| Decision Date | 1996-05-06 |
| Summary: | summary |