The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Delta D-750 Thermaflow.
Device ID | K790406 |
510k Number | K790406 |
Device Name: | DELTA D-750 THERMAFLOW |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-26 |
Decision Date | 1979-11-13 |