Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K891282 |
Device Name |
MIC-100 WITH CRYOPROBES |
Applicant |
FRIGITRONICS OF CONNECTICUT, INC. |
770 RIVER RD. |
P.O. BOX 855 |
SHELTON,
CT
06484
|
|
Applicant Contact |
FRANK HALLETT |
Correspondent |
FRIGITRONICS OF CONNECTICUT, INC. |
770 RIVER RD. |
P.O. BOX 855 |
SHELTON,
CT
06484
|
|
Correspondent Contact |
FRANK HALLETT |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 03/09/1989 |
Decision Date | 06/15/1989 |
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
|
|
|