Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K102006 |
Device Name |
CRYOMEGA |
Applicant |
STC CONSULTING LLC |
4093 MAULFAIR DRIVE |
ALLENTOWN,
PA
18103
|
|
Applicant Contact |
R. SAM NIEDBALA |
Correspondent |
STC CONSULTING LLC |
4093 MAULFAIR DRIVE |
ALLENTOWN,
PA
18103
|
|
Correspondent Contact |
R. SAM NIEDBALA |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 07/16/2010 |
Decision Date | 10/06/2010 |
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
|