Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K173901 |
Device Name |
MyoSure MANUAL Tissue Removal Device |
Applicant |
Hologic, Inc. |
250 Campus Drive |
Marlbrough,
MA
01752
|
|
Applicant Contact |
Anne-Marie Keefe |
Correspondent |
Hologic, Inc. |
250 Campus Drive |
Marlbrough,
MA
01752
|
|
Correspondent Contact |
Anne-Marie Keefe |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 12/22/2017 |
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
|
|
|