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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K091890
Device Name EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT
Applicant
Healthpoint, Ltd.
3909 Hulen St.
Fort Worth,  TX  76107
Applicant Contact AMY CAMPBELL
Correspondent
Healthpoint, Ltd.
3909 Hulen St.
Fort Worth,  TX  76107
Correspondent Contact AMY CAMPBELL
Regulation Number880.6885
Classification Product Code
MED  
Date Received06/23/2009
Decision Date 03/24/2010
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
Predetermined Change
Control Plan Authorized		 No
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