Device Classification Name |
forceps, surgical, gynecological
|
510(k) Number |
K172661 |
Device Name |
Fetzer Medical Gynecological Forceps |
Applicant |
Fetzer Medical GmbH & Co. KG |
Unter Buchsteig 5 |
Tuttlingen,
DE
78532
|
|
Applicant Contact |
Harald Jung |
Correspondent |
Fetzer Medical GmbH & Co. KG |
Unter Buchsteig 5 |
Tuttlingen,
DE
78532
|
|
Correspondent Contact |
Harald Jung |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/05/2017 |
Decision Date | 05/08/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|