Device Classification Name |
Snare, Flexible
|
510(k) Number |
K941750 |
Device Name |
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES |
Applicant |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
WATERTOWN,
MA
02472 -2407
|
|
Applicant Contact |
CHRISTINE M HARRIS |
Correspondent |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
WATERTOWN,
MA
02472 -2407
|
|
Correspondent Contact |
CHRISTINE M HARRIS |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 04/08/1994 |
Decision Date | 11/01/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|