Device Classification Name |
Stent, Ureteral
|
510(k) Number |
K831446 |
Device Name |
SURGITEK NEPHROSTENT KIT |
Applicant |
MEC/SURGITEK PRODUCTS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MEC/SURGITEK PRODUCTS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 05/05/1983 |
Decision Date | 06/22/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|