The following data is part of a premarket notification filed by Medi-dose, Inc. with the FDA for Safe Cap Needle Recapping/uncapping Device.
| Device ID | K952518 |
| 510k Number | K952518 |
| Device Name: | SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDI-DOSE, INC. 1671 LORETTA AVE. Feasterville, PA 19053 |
| Contact | Robert Braveman |
| Correspondent | Robert Braveman MEDI-DOSE, INC. 1671 LORETTA AVE. Feasterville, PA 19053 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-17 |
| Decision Date | 1995-07-28 |