Device Classification Name |
Cystourethroscope
|
510(k) Number |
K904797 |
Device Name |
SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) |
Applicant |
SURGITEK |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Applicant Contact |
STEVE APERAVICH |
Correspondent |
SURGITEK |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Correspondent Contact |
STEVE APERAVICH |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/23/1990 |
Decision Date | 03/05/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|