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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 K041360
Device Name ALDAHOL III HIGH-LEVEL DISINFECTANT
Applicant
Healthpoint, Ltd.
1107-C S. Airport Cir.
Euless,  TX  76040
Applicant Contact NORM MINER, PHD
Correspondent
Healthpoint, Ltd.
1107-C S. Airport Cir.
Euless,  TX  76040
Correspondent Contact NORM MINER, PHD
Regulation Number880.6885
Classification Product Code
MED  
Date Received05/21/2004
Decision Date 05/05/2005
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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