Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K940140 |
Device Name |
HM-CRYO |
Applicant |
HILL-MED, INC. |
7217 N.W. 46TH ST. |
MIAMI,
FL
33166
|
|
Applicant Contact |
ERNESTO ACKERMAN |
Correspondent |
HILL-MED, INC. |
7217 N.W. 46TH ST. |
MIAMI,
FL
33166
|
|
Correspondent Contact |
ERNESTO ACKERMAN |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 01/11/1994 |
Decision Date | 06/27/1994 |
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
|
|
|