Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K133375 |
Device Name |
BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR |
Applicant |
BANYAN MEDICAL, LLC. |
89 BELLOWS STREET |
WARWICK,
RI
02888
|
|
Applicant Contact |
TAMMY HEALEY |
Correspondent |
BANYAN MEDICAL, LLC. |
89 BELLOWS STREET |
WARWICK,
RI
02888
|
|
Correspondent Contact |
TAMMY HEALEY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/04/2013 |
Decision Date | 01/17/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|