The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Biocor 200 High Performanceoxygenator.
| Device ID | K964967 |
| 510k Number | K964967 |
| Device Name: | BIOCOR 200 HIGH PERFORMANCEOXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Richard Goldhaber |
| Correspondent | Richard Goldhaber MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-10 |
| Decision Date | 1997-03-06 |