Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K200038 |
Device Name |
Endosee System |
Applicant |
CooperSurgical, Inc. |
95 Corporate Drive |
Trumbull,
CT
06611
|
|
Applicant Contact |
Christine Kupchick |
Correspondent |
CooperSurgical, Inc. |
95 Corporate Drive |
Trumbull,
CT
06611
|
|
Correspondent Contact |
Christine Kupchick |
Regulation Number | 884.1690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/08/2020 |
Decision Date | 02/05/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|