The following data is part of a premarket notification filed by Daily Medical Products, Inc. with the FDA for Topical Cooling Pad, Model 7000.
Device ID | K905568 |
510k Number | K905568 |
Device Name: | TOPICAL COOLING PAD, MODEL 7000 |
Classification | Heat-exchanger, 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 | DTR |
CFR Regulation Number | 870.4240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-12 |
Decision Date | 1991-01-23 |