The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Cardiotomy Reservoir Cr-2000.
Device ID | K790116 |
510k Number | K790116 |
Device Name: | CARDIOTOMY RESERVOIR CR-2000 |
Classification | Permanent Pacemaker Electrode |
Applicant | DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTB |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-22 |
Decision Date | 1979-02-08 |