Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K172769 |
Device Name |
CryOmega Flexx |
Applicant |
CryoConcepts LP |
205 Webster Street |
Bethlehem,
PA
18015
|
|
Applicant Contact |
R Sam Niedbala |
Correspondent |
CryoConcepts LP |
205 Webster Street |
Bethlehem,
PA
18015
|
|
Correspondent Contact |
R Sam Niedbala |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 09/13/2017 |
Decision Date | 11/30/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|