The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Mini-op Ats Blood Recovery Bag, Moel 2950.
| Device ID | K912609 |
| 510k Number | K912609 |
| Device Name: | MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950 |
| Classification | Apparatus, Autotransfusion |
| Applicant | ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis, NH 03049 |
| Contact | Ted Karwoski |
| Correspondent | Ted Karwoski ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis, NH 03049 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-12 |
| Decision Date | 1991-11-29 |