| Device Classification Name |
Pad, Alcohol, Device Disinfectant
|
| 510(k) Number |
K912731 |
| Device Name |
STERI-SWAB |
| Applicant |
| Westlock Investments (Usa), Inc. |
| 15924 NE 27th Place |
|
Bellevue,
WA
98008
|
|
| Applicant Contact |
KELVIN MARIAPRAGASAM |
| Correspondent |
| Westlock Investments (Usa), Inc. |
| 15924 NE 27th Place |
|
Bellevue,
WA
98008
|
|
| Correspondent Contact |
KELVIN MARIAPRAGASAM |
| Classification Product Code |
|
| Date Received | 06/20/1991 |
| Decision Date | 10/02/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|