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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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
LKB  
Date Received06/20/1991
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
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