The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for In-line Ats Blood Recovery Bag.
| Device ID | K904794 |
| 510k Number | K904794 |
| Device Name: | IN-LINE ATS BLOOD RECOVERY BAG |
| 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 | 1990-10-23 |
| Decision Date | 1991-01-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20650862125508 | K904794 | 000 |