Device Classification Name |
Dilator, Urethral
|
510(k) Number |
K792219 |
Device Name |
VANCE MALLEABLE TIP FILIFORM |
Applicant |
VANCE PRODUCTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
VANCE PRODUCTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5520 |
Classification Product Code |
|
Date Received | 11/05/1979 |
Decision Date | 12/06/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|