K946190 is an FDA 510(k) clearance for the DRUG DISPENSING SPIKE. This device is classified as a Syringe, Piston (Class II — Special Controls, product code FMF).
Submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on March 17, 1995, 87 days after receiving the submission on December 20, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K946190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1994 |
| Decision Date | March 17, 1995 |
| Days to Decision | 87 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 |