The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Prebypass Filter.
Device ID | K780485 |
510k Number | K780485 |
Device Name: | PREBYPASS FILTER |
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 | 1978-03-27 |
Decision Date | 1978-04-05 |