Device Classification Name |
mini endoscope, gastroenterology-urology
|
510(k) Number |
K052194 |
Device Name |
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR |
Applicant |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
ALLYSON BARFORD |
Correspondent |
INTERTEK TESTING SERVICES |
70 CODMAN HILL RD. |
BOXBOROUGH,
MA
01719
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/11/2005 |
Decision Date | 08/24/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|