Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K942329 |
Device Name |
HAND CONTROLLED SYRINGE |
Applicant |
ABBOTT LABORATORIES |
D-389, AP-30 |
200 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -3537
|
|
Applicant Contact |
FREDERICK A GUSTAFSON |
Correspondent |
ABBOTT LABORATORIES |
D-389, AP-30 |
200 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -3537
|
|
Correspondent Contact |
FREDERICK A GUSTAFSON |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 05/16/1994 |
Decision Date | 06/20/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|