Device Classification Name |
Dislodger, Stone, Basket, Ureteral, Metal
|
510(k) Number |
K831875 |
Device Name |
BALLOON DILATION HELICAL STONE EXTRACT |
Applicant |
VPI |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
VPI |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.4680
|
Classification Product Code |
|
Date Received | 06/13/1983 |
Decision Date | 09/12/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|