Device Classification Name |
Stent, Ureteral
|
510(k) Number |
K871667 |
Device Name |
URETERAL STENT |
Applicant |
PENN MEDICAL DEVICES, INC. |
12 RIDGE ST. |
BASKING RIDGE,
NJ
07920
|
|
Applicant Contact |
ANN SALTARELLI |
Correspondent |
PENN MEDICAL DEVICES, INC. |
12 RIDGE ST. |
BASKING RIDGE,
NJ
07920
|
|
Correspondent Contact |
ANN SALTARELLI |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 04/28/1987 |
Decision Date | 06/10/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|