Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K760686 |
Device Name |
CRYOLYZER ALPHA (CRYOSURG.EQUIP.) |
Applicant |
CRYO-LABS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CRYO-LABS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 09/20/1976 |
Decision Date | 11/01/1976 |
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
|