K955282 is an FDA 510(k) clearance for the THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Thermogenesis Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on May 6, 1996, 172 days after receiving the submission on November 16, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K955282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 1995 |
| Decision Date | May 06, 1996 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |