Device Classification Name |
catheter, balloon type
|
510(k) Number |
K781772 |
Device Name |
CATHETER, TRANSLUMINAL BALLOON |
Applicant |
MEDI-TECH, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MEDI-TECH, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 10/16/1978 |
Decision Date | 03/06/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|