Device Classification Name |
Forceps, Biopsy, Electric
|
510(k) Number |
K160625 |
Device Name |
Disposable Hot Biopsy Forceps |
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 | 03/04/2016 |
Decision Date | 06/14/2016 |
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
|
|
|