Device Classification Name |
Sigmoidoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K932843 |
Device Name |
FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH |
Applicant |
VISION-SCIENCES, INC. |
6 STRATHMORE RD. |
NATICK,
MA
01760
|
|
Applicant Contact |
DEBBIE IAMPIETRO |
Correspondent |
VISION-SCIENCES, INC. |
6 STRATHMORE RD. |
NATICK,
MA
01760
|
|
Correspondent Contact |
DEBBIE IAMPIETRO |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/11/1993 |
Decision Date | 02/14/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|