The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Mini-op Ats Blood Recovery Bag, Model 2955.
Device ID | K912610 |
510k Number | K912610 |
Device Name: | MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955 |
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 |