Device Classification Name |
catheter, flow directed
|
510(k) Number |
K820229 |
Device Name |
NORTON FLOW DIRECTED THERMODILUTION CATH |
Applicant |
NORTON PERFORMANCE PLASTICS CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
NORTON PERFORMANCE PLASTICS CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.1240
|
Classification Product Code |
|
Date Received | 01/27/1982 |
Decision Date | 02/12/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|