The following data is part of a premarket notification filed by Fresenius Hemotechnology, Inc. with the FDA for Fresenius Atr40 And Atr120 Autotransfusion Reservoirs.
| Device ID | K984586 |
| 510k Number | K984586 |
| Device Name: | FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | FRESENIUS HEMOTECHNOLOGY, INC. 110 MASON CIRCLE SUITE A Concord, CA 94520 -1238 |
| Contact | Virginia R Singer |
| Correspondent | Virginia R Singer FRESENIUS HEMOTECHNOLOGY, INC. 110 MASON CIRCLE SUITE A Concord, CA 94520 -1238 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-24 |
| Decision Date | 1999-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04052682000775 | K984586 | 000 |
| 04052682000508 | K984586 | 000 |
| 04052682000492 | K984586 | 000 |