The following data is part of a premarket notification filed by Ocean Medical Products, Ltd. with the FDA for Single Wall Introducer Needle.
| Device ID | K843719 |
| 510k Number | K843719 |
| Device Name: | SINGLE WALL INTRODUCER NEEDLE |
| Classification | Introducer, Catheter |
| Applicant | OCEAN MEDICAL PRODUCTS, LTD. 2131 MARTINDALE Wyoming, MI 49509 |
| Contact | Alan Taylor |
| Correspondent | Alan Taylor OCEAN MEDICAL PRODUCTS, LTD. 2131 MARTINDALE Wyoming, MI 49509 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-24 |
| Decision Date | 1984-10-18 |