The following data is part of a premarket notification filed by Ocean Medical Products, Ltd. with the FDA for Percutaneous Entry Needle, Seldinger.
| Device ID | K813461 |
| 510k Number | K813461 |
| Device Name: | PERCUTANEOUS ENTRY NEEDLE, SELDINGER |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | OCEAN MEDICAL PRODUCTS, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-11 |
| Decision Date | 1981-12-29 |