Device Classification Name |
Cystourethroscope
|
510(k) Number |
K941992 |
Device Name |
CYSTOSCOPE |
Applicant |
SURGICAL TECHNOLOGIES, INC. |
4715 N.W. 157TH. STREET, |
SUITE 124 |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
LASZLO FAZEKAS |
Correspondent |
SURGICAL TECHNOLOGIES, INC. |
4715 N.W. 157TH. STREET, |
SUITE 124 |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
LASZLO FAZEKAS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/25/1994 |
Decision Date | 11/30/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|