Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K982280 |
Device Name |
CRYOPRO MAXI AND CRYOPRO MINI |
Applicant |
CORTEX TECHNOLOGY APS |
1050 CONNECTICUT AVENUE NW |
WASHINGTON,
DC
20036 -5339
|
|
Applicant Contact |
MARSHA WERTZBERGER |
Correspondent |
CORTEX TECHNOLOGY APS |
1050 CONNECTICUT AVENUE NW |
WASHINGTON,
DC
20036 -5339
|
|
Correspondent Contact |
MARSHA WERTZBERGER |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 06/30/1998 |
Decision Date | 11/25/1998 |
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
|