Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K871796 |
Device Name |
NUMED PTA CATHETERS |
Applicant |
NUMED, INC. |
MAIN ST. |
HOPKINTON,
NY
12940
|
|
Applicant Contact |
ALLEN J TOWER |
Correspondent |
NUMED, INC. |
MAIN ST. |
HOPKINTON,
NY
12940
|
|
Correspondent Contact |
ALLEN J TOWER |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 05/07/1987 |
Decision Date | 12/03/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|