The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Prebypass Filter Cat.#k-5.
| Device ID | K803101 |
| 510k Number | K803101 |
| Device Name: | PREBYPASS FILTER CAT.#K-5 |
| Classification | Filter, Prebypass, Cardiopulmonary Bypass |
| Applicant | DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRJ |
| CFR Regulation Number | 870.4280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-09 |
| Decision Date | 1980-12-22 |