The following data is part of a premarket notification filed by Medelec Intl. Corp. with the FDA for Disposable Syringes & Needles.
| Device ID | K854563 |
| 510k Number | K854563 |
| Device Name: | DISPOSABLE SYRINGES & NEEDLES |
| Classification | Syringe, Piston |
| Applicant | MEDELEC INTL. CORP. ONE LINCOLN ROAD, SUITE 304 Miami Beach, FL 33139 |
| Contact | Oscar D Docal |
| Correspondent | Oscar D Docal MEDELEC INTL. CORP. ONE LINCOLN ROAD, SUITE 304 Miami Beach, FL 33139 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-14 |
| Decision Date | 1985-12-09 |