Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K914119 |
Device Name |
DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM |
Applicant |
DAVOL, INC. |
100 SOCKANOSSETT CROSSROAD |
P.O. BOX 8500 |
CRANSTON,
RI
02920
|
|
Applicant Contact |
ROBIN M DRAGO |
Correspondent |
DAVOL, INC. |
100 SOCKANOSSETT CROSSROAD |
P.O. BOX 8500 |
CRANSTON,
RI
02920
|
|
Correspondent Contact |
ROBIN M DRAGO |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 09/13/1991 |
Decision Date | 12/03/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|