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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Disinfector, Medical Devices
510(k) Number K911120
Device Name DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21
Applicant
Hamo USA, Inc.
10100 NW 116th Way, Suite 14
Miami,  FL  33178
Applicant Contact ALFREDO MUNOZ
Correspondent
Hamo USA, Inc.
10100 NW 116th Way, Suite 14
Miami,  FL  33178
Correspondent Contact ALFREDO MUNOZ
Regulation Number880.6992
Classification Product Code
MEC  
Date Received03/11/1991
Decision Date 02/03/1994
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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