The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Drug Dispensing Spike.
| Device ID | K946190 |
| 510k Number | K946190 |
| Device Name: | DRUG DISPENSING SPIKE |
| Classification | Syringe, Piston |
| Applicant | GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019 |
| Contact | Mitchell L Ehrlich |
| Correspondent | Mitchell L Ehrlich GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-20 |
| Decision Date | 1995-03-17 |