The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Heat Exchanger Coil.
| Device ID | K790756 |
| 510k Number | K790756 |
| Device Name: | HEAT EXCHANGER COIL |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-17 |
| Decision Date | 1979-06-11 |