The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Disposable Syringes And Disposable Needles.
| Device ID | K945225 |
| 510k Number | K945225 |
| Device Name: | DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES |
| Classification | Syringe, Piston |
| Applicant | MYCO MEDICAL SUPPLIES, INC. 6640 PORTSMOUTH LN. Raleigh, NC 27615 |
| Contact | Sanjiv K Kumar |
| Correspondent | Sanjiv K Kumar MYCO MEDICAL SUPPLIES, INC. 6640 PORTSMOUTH LN. Raleigh, NC 27615 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-26 |
| Decision Date | 1995-01-26 |