Device Classification Name |
lithotriptor, electro-hydraulic
|
510(k) Number |
K072422 |
Device Name |
CYBERWAND STERILE PADS, MODEL: CW-RBPBX |
Applicant |
CYBERSONICS, INC. |
5368 KUHL RD. |
ERIE,
PA
16510 -4703
|
|
Applicant Contact |
WILLIAM A STOLL |
Correspondent |
CYBERSONICS, INC. |
5368 KUHL RD. |
ERIE,
PA
16510 -4703
|
|
Correspondent Contact |
WILLIAM A STOLL |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 08/28/2007 |
Decision Date | 10/24/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|