The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Stanicor, Omni-stan,mod 333b,334a Gamma.
| Device ID | K792348 |
| 510k Number | K792348 |
| Device Name: | STANICOR, OMNI-STAN,MOD 333B,334A GAMMA |
| Classification | Gas Control Unit, Cardiopulmonary Bypass |
| Applicant | CORDIS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTX |
| CFR Regulation Number | 870.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-19 |
| Decision Date | 1979-12-05 |