Device Classification Name |
biopsy needle
|
510(k) Number |
K133008 |
Device Name |
BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED, |
Applicant |
BEACON ENDOSCOPIC |
2000 COMMONWEALTH AVE STE 110 |
AUBURNDALE,
MA
02466
|
|
Applicant Contact |
ANNETTE M FAGNANT |
Correspondent |
BEACON ENDOSCOPIC |
2000 COMMONWEALTH AVE STE 110 |
AUBURNDALE,
MA
02466
|
|
Correspondent Contact |
ANNETTE M FAGNANT |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 09/25/2013 |
Decision Date | 11/20/2013 |
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
|
|
|