The following data is part of a premarket notification filed by Researched, Novel Medical Devices (rn/md) with the FDA for Split Top Wing Needle Cap With Optional Tubing Anchors (and Appropriate Recap Device.
| Device ID | K944680 |
| 510k Number | K944680 |
| Device Name: | SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | RESEARCHED, NOVEL MEDICAL DEVICES (RN/MD) 4480 SHERMAN OAKS CIRCLE Sherman Oaks, CA 91403 |
| Contact | Annabelle D Tucker |
| Correspondent | Annabelle D Tucker RESEARCHED, NOVEL MEDICAL DEVICES (RN/MD) 4480 SHERMAN OAKS CIRCLE Sherman Oaks, CA 91403 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-22 |
| Decision Date | 1995-01-31 |