The following data is part of a premarket notification filed by Daily Medical Products, Inc. with the FDA for Cardiac Cooling Jacket, 12 Cm, Model Cj-520.
Device ID | K896972 |
510k Number | K896972 |
Device Name: | CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 |
Classification | Controller, Temperature, Cardiopulmonary Bypass |
Applicant | DAILY MEDICAL PRODUCTS, INC. 3665 KEARNY VILLA RD. STE 301 San Diego, CA 92123 |
Contact | Alan Seacord |
Correspondent | Alan Seacord DAILY MEDICAL PRODUCTS, INC. 3665 KEARNY VILLA RD. STE 301 San Diego, CA 92123 |
Product Code | DWC |
CFR Regulation Number | 870.4250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-13 |
Decision Date | 1990-02-05 |