Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K854767 |
Device Name |
LM 1000 |
Applicant |
LEISEGANG MEDICAL, INC. |
8801 S.W. 129 STREET |
MIAMI,
FL
33176
|
|
Applicant Contact |
DOUGLAS KWART |
Correspondent |
LEISEGANG MEDICAL, INC. |
8801 S.W. 129 STREET |
MIAMI,
FL
33176
|
|
Correspondent Contact |
DOUGLAS KWART |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 11/27/1985 |
Decision Date | 01/24/1986 |
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
|
|
|