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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 K833185
Device Name ACETONE ALCOHOL PREP PAD
Applicant
Aplicare, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Aplicare, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
LKB  
Date Received09/19/1983
Decision Date 10/31/1983
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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