Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K173070 |
Device Name |
HSW Resection Instruments |
Applicant |
Henke-Sass, Wolf GmbH |
Keltenstrasse 1 |
Tuttlingen,
DE
78532
|
|
Applicant Contact |
Anna Reifschneider |
Correspondent |
Henke-Sass, Wolf GmbH |
Keltenstrasse 1 |
Tuttlingen,
DE
78532
|
|
Correspondent Contact |
Anna Reifschneider |
Regulation Number | 884.1690
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/29/2017 |
Decision Date | 06/08/2018 |
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
|
|
|