The following data is part of a premarket notification filed by Evans Medical, Inc. with the FDA for Medical Specialties Non-coring Needle Admin Sets.
| Device ID | K935480 |
| 510k Number | K935480 |
| Device Name: | MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | EVANS MEDICAL, INC. 2976 WINDY BUSH RD. P.O. BOX 326 Pineville, PA 18946 |
| Contact | David W Evans |
| Correspondent | David W Evans EVANS MEDICAL, INC. 2976 WINDY BUSH RD. P.O. BOX 326 Pineville, PA 18946 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-25 |
| Decision Date | 1994-01-28 |