The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Cardioplegia Cooling & Admin. Sets.
| Device ID | K811368 |
| 510k Number | K811368 |
| Device Name: | CARDIOPLEGIA COOLING & ADMIN. SETS |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-14 |
| Decision Date | 1981-06-09 |