The following data is part of a premarket notification filed by Franklin Medical Usa, Inc. with the FDA for Frantz Medical Sharps Collector.
| Device ID | K884589 |
| 510k Number | K884589 |
| Device Name: | FRANTZ MEDICAL SHARPS COLLECTOR |
| Classification | Syringe, Piston |
| Applicant | FRANKLIN MEDICAL USA, INC. 7740 METRIC DR. Mentor, OH 44060 |
| Contact | Mark G Frantz |
| Correspondent | Mark G Frantz FRANKLIN MEDICAL USA, INC. 7740 METRIC DR. Mentor, OH 44060 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-03 |
| Decision Date | 1988-12-09 |