The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Ats Blood Recovery Bag.
| Device ID | K883663 |
| 510k Number | K883663 |
| Device Name: | 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 | 1988-08-26 |
| Decision Date | 1988-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20650862124501 | K883663 | 000 |