Device Classification Name |
insufflator, hysteroscopic
|
510(k) Number |
K172048 |
Device Name |
FluidSmart |
Applicant |
THERMEDX, LLC |
31200 Solon Rd., Unit #1 |
Solon,
OH
44139
|
|
Applicant Contact |
Homer Gregory |
Correspondent |
THERMEDX, LLC |
31200 Solon Rd., Unit #1 |
Solon,
OH
44139
|
|
Correspondent Contact |
Homer Gregory |
Regulation Number | 884.1700
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/06/2017 |
Decision Date | 09/05/2017 |
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
|
|
|