Device Classification Name |
biopsy needle
|
510(k) Number |
K100712 |
Device Name |
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE |
Applicant |
Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
ASHLEY PYLE |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 876.1075
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/12/2010 |
Decision Date | 03/30/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|