Device Classification Name |
Stent, Ureteral
|
510(k) Number |
K910691 |
Device Name |
NORTEC URETERAL STENT |
Applicant |
NORTH AMERICAN STERILIZATION & PACKAGING CO. |
15 WHITE LAKE RD. |
P.O. BOX 923 |
SPARTA,
NJ
07871
|
|
Applicant Contact |
HARRY A SCHLAKMAN |
Correspondent |
NORTH AMERICAN STERILIZATION & PACKAGING CO. |
15 WHITE LAKE RD. |
P.O. BOX 923 |
SPARTA,
NJ
07871
|
|
Correspondent Contact |
HARRY A SCHLAKMAN |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 02/19/1991 |
Decision Date | 08/15/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|