Device Classification Name |
forceps, biopsy, electric
|
510(k) Number |
K183428 |
Device Name |
Avulsion Forceps |
Applicant |
STERIS Corporation |
5976 Heisley Rd |
Mentor,
OH
44060
|
|
Applicant Contact |
Eileen McCafferty |
Correspondent |
STERIS Corporation |
5976 Heisley Rd |
Mentor,
OH
44060
|
|
Correspondent Contact |
Eileen McCafferty |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 12/11/2018 |
Decision Date | 04/16/2019 |
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
|
|
|