Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K152203 |
Device Name |
UTERMOHLEN CRYO PROFESSIONAL |
Applicant |
KONINKLIJKE (ROYAL) UTERMOHLEN |
DEE OVERWEG 1 |
WOLVEGA,
NL
8471ZA
|
|
Applicant Contact |
MR.D VAN HOOF |
Correspondent |
KRM ASSOCIATES |
17751 FRONDOSA DRIVE |
SAN DIEGO,
CA
92128
|
|
Correspondent Contact |
DR K R MICHAEL |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 08/06/2015 |
Decision Date | 11/06/2015 |
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
|