Device Classification Name |
Snare, Flexible
|
510(k) Number |
K992477 |
Device Name |
ROTOSNARE |
Applicant |
INSCOPE, LLC. |
19526 EAST LAKE DR. |
MIAMI,
FL
33015
|
|
Applicant Contact |
AL WEISENBORN |
Correspondent |
INSCOPE, LLC. |
19526 EAST LAKE DR. |
MIAMI,
FL
33015
|
|
Correspondent Contact |
AL WEISENBORN |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 07/26/1999 |
Decision Date | 08/24/1999 |
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
|
|
|