The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol Autotransfusion Blood Processing System.
| Device ID | K901401 |
| 510k Number | K901401 |
| Device Name: | DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Annette M Fagnant |
| Correspondent | Annette M Fagnant DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-26 |
| Decision Date | 1990-10-23 |