Device Classification Name |
Dislodger, Stone, Basket, Ureteral, Metal
|
510(k) Number |
K862729 |
Device Name |
PENN 3-RING HANDLE |
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 | 876.4680
|
Classification Product Code |
|
Date Received | 07/18/1986 |
Decision Date | 10/24/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|