Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K172049 |
Device Name |
CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED |
Applicant |
Cry IQ AB |
Apelrodsvagen 1 |
Onsala,
SE
43932
|
|
Applicant Contact |
Stefan Skafte |
Correspondent |
M Squared Associates, Inc |
515 Eight Avenue, st 1212 |
New York,
NY
10018
|
|
Correspondent Contact |
Cherita James |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 07/06/2017 |
Decision Date | 08/30/2017 |
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
|
|
|