Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K904888 |
Device Name |
AUTOWAND(TM) 7XXX SERIES, MODIFICATION |
Applicant |
BOEHRINGER LABORATORIES |
P.O. BOX 870 |
NORRISTOWN,
PA
19404
|
|
Applicant Contact |
JOHN KARPOWICZ |
Correspondent |
BOEHRINGER LABORATORIES |
P.O. BOX 870 |
NORRISTOWN,
PA
19404
|
|
Correspondent Contact |
JOHN KARPOWICZ |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 10/26/1990 |
Decision Date | 01/16/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|