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 |