Device Classification Name |
Insufflator, Hysteroscopic
|
510(k) Number |
K133799 |
Device Name |
THERMEDX FLUID MANAGMENT SYSTEM |
Applicant |
THERMEDX LLC |
31200 SOLON RD., UNIT #1 |
SOLON,
OH
44139
|
|
Applicant Contact |
JEFF WILLIAMS |
Correspondent |
THERMEDX LLC |
31200 SOLON RD., UNIT #1 |
SOLON,
OH
44139
|
|
Correspondent Contact |
JEFF WILLIAMS |
Regulation Number | 884.1700
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/13/2013 |
Decision Date | 06/20/2014 |
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
|
|
|