Device Classification Name |
snare, flexible
|
510(k) Number |
K150316 |
Device Name |
Polypectomy Snare |
Applicant |
MICRO- TECH (NANJING) CO., LTD. |
NO. 10 GAOKE THIRD ROAD |
NANJING,
CN
210032
|
|
Applicant Contact |
BECKY LI |
Correspondent |
MICRO- TECH (NANJING) CO., LTD. |
NO. 10 GAOKE THIRD ROAD |
NANJING,
CN
210032
|
|
Correspondent Contact |
BECKY LI |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 02/09/2015 |
Decision Date | 07/30/2015 |
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
|
|
|