Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K060859 |
Device Name |
COMPOUND W FREEZE OFF WART REMOVAL SYSTEM |
Applicant |
ORASURE TECHNOLOGIES, INC. |
150 WEBSTER ST. |
BETHELEHEM,
PA
18015 -1389
|
|
Applicant Contact |
SUE SUTTON-JONES |
Correspondent |
ORASURE TECHNOLOGIES, INC. |
150 WEBSTER ST. |
BETHELEHEM,
PA
18015 -1389
|
|
Correspondent Contact |
SUE SUTTON-JONES |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 03/28/2006 |
Decision Date | 07/18/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|