Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K964971 |
Device Name |
CRYOGEN CRYOSURGICAL SYSTEM |
Applicant |
CRYOGEN, INC. |
6199 CORNERSTONE COURT EAST |
SUITE 106 |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
JOHN DOBAK |
Correspondent |
CRYOGEN, INC. |
6199 CORNERSTONE COURT EAST |
SUITE 106 |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
JOHN DOBAK |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 12/12/1996 |
Decision Date | 03/28/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|