Device Classification Name |
cap, device disinfectant
|
510(k) Number |
K080466 |
Device Name |
ALCOHOL PAD |
Applicant |
122 CORPORATION |
3525 DEL MAR HEIGHTS |
SUITE 430 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
DONALD CANAL |
Correspondent |
122 CORPORATION |
3525 DEL MAR HEIGHTS |
SUITE 430 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
DONALD CANAL |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/21/2008 |
Decision Date | 10/21/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|