The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Norton Cardioplegic Quick Cooling Coil 421738-000.
| Device ID | K853791 |
| 510k Number | K853791 |
| Device Name: | NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. P.O. BOX 3660 Akron, OH 44309 |
| Contact | Christine D Enger |
| Correspondent | Christine D Enger NORTON PERFORMANCE PLASTICS CORP. P.O. BOX 3660 Akron, OH 44309 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-11 |
| Decision Date | 1985-12-09 |