Device Classification Name |
Sigmoidoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K963344 |
Device Name |
DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE |
Applicant |
VISION-SCIENCES, INC. |
6 STRATHMORE RD. |
NATICK,
MA
01760
|
|
Applicant Contact |
PAMELA PAPINEAU |
Correspondent |
VISION-SCIENCES, INC. |
6 STRATHMORE RD. |
NATICK,
MA
01760
|
|
Correspondent Contact |
PAMELA PAPINEAU |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/26/1996 |
Decision Date | 11/21/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|