Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K150158 |
Device Name |
Schoelly Cystoscopes/Hysteroscopes and Accessories |
Applicant |
Schoelly Fiberoptic GmbH |
Robert-Bosch-Str. 1-3 |
Denzlingen,
DE
79211
|
|
Applicant Contact |
Sandra Baumann |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 884.1690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/23/2015 |
Decision Date | 03/09/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|