Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K012214 |
Device Name |
CRYOPEN AND ACCESSORIES |
Applicant |
CIMEX BIOTECH, LLC. |
72385 INDUSTRY PARK |
COVINGTON,
LA
70435
|
|
Applicant Contact |
MICHAEL HAAS |
Correspondent |
CIMEX BIOTECH, LLC. |
72385 INDUSTRY PARK |
COVINGTON,
LA
70435
|
|
Correspondent Contact |
MICHAEL HAAS |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 07/16/2001 |
Decision Date | 04/26/2002 |
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
|
|
|