The following data is part of a premarket notification filed by Ocean Medical Products, Ltd. with the FDA for Potts-cournand Style Needle.
| Device ID | K813448 |
| 510k Number | K813448 |
| Device Name: | POTTS-COURNAND STYLE NEEDLE |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | OCEAN MEDICAL PRODUCTS, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-11 |
| Decision Date | 1982-01-07 |