Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K941978 |
Device Name |
HIGH PRESSURE TUBING |
Applicant |
ABBOTT LABORATORIES |
D-389, AP-30 |
200 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -3537
|
|
Applicant Contact |
FREDERIK A GUSTAFSON |
Correspondent |
ABBOTT LABORATORIES |
D-389, AP-30 |
200 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -3537
|
|
Correspondent Contact |
FREDERIK A GUSTAFSON |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 04/14/1994 |
Decision Date | 12/13/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|