The following data is part of a premarket notification filed by Osborn Medical Corp. with the FDA for Cord Wrap With Needle Resheather.
| Device ID | K960963 |
| 510k Number | K960963 |
| Device Name: | CORD WRAP WITH NEEDLE RESHEATHER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | OSBORN MEDICAL CORP. 100 WEST MAIN Utica, MN 55979 |
| Contact | Bill D Davis |
| Correspondent | Bill D Davis OSBORN MEDICAL CORP. 100 WEST MAIN Utica, MN 55979 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-11 |
| Decision Date | 1996-05-06 |
| Summary: | summary |