The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for S3 Cardioplegia Control.
| Device ID | K962320 |
| 510k Number | K962320 |
| Device Name: | S3 CARDIOPLEGIA CONTROL |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Diane Minear |
| Correspondent | Diane Minear STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1997-01-10 |
| Summary: | summary |