The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Topical Cooling Dev. Tcd. #27-999.
| Device ID | K800717 |
| 510k Number | K800717 |
| Device Name: | TOPICAL COOLING DEV. TCD. #27-999 |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-31 |
| Decision Date | 1980-04-16 |