The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Stockert-shiley Heater/cooler Temperature Control.
| Device ID | K860920 |
| 510k Number | K860920 |
| Device Name: | STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Morton Barak |
| Correspondent | Morton Barak SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-11 |
| Decision Date | 1986-05-21 |