The following data is part of a premarket notification filed by Ocean Medical Products, Ltd. with the FDA for Soft Tissue Biopsy Device.
| Device ID | K882013 |
| 510k Number | K882013 |
| Device Name: | SOFT TISSUE BIOPSY DEVICE |
| Classification | Needle, Biopsy, Cardiovascular |
| 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 | DWO |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-13 |
| Decision Date | 1988-06-15 |