The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Arterial Bubble Trap K-20.
Device ID | K803102 |
510k Number | K803102 |
Device Name: | ARTERIAL BUBBLE TRAP K-20 |
Classification | Detector, Bubble, Cardiopulmonary Bypass |
Applicant | DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRL |
CFR Regulation Number | 870.4205 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-09 |
Decision Date | 1980-12-22 |