Device Classification Name |
cystourethroscope
|
510(k) Number |
K061646 |
Device Name |
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES |
Applicant |
LASERSCOPE |
3070 ORCHARD DR. |
SAN JOSE,
CA
95134 -2011
|
|
Applicant Contact |
PAUL HARDIMAN |
Correspondent |
KEMA QUALITY B.V. |
4377 COUNTY LINE ROAD |
CHALFONT,
PA
18914
|
|
Correspondent Contact |
PATRICIA L MURPHY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/12/2006 |
Decision Date | 06/27/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|