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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Ethylene-Oxide Gas
510(k) Number K014013
Device Name H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM
Applicant
H & W Technology, LLC
P.O. Box 20281
Rochester,  NY  14602 -0281
Applicant Contact CHARLES O HANCOCK
Correspondent
H & W Technology, LLC
P.O. Box 20281
Rochester,  NY  14602 -0281
Correspondent Contact CHARLES O HANCOCK
Regulation Number880.6860
Classification Product Code
FLF  
Date Received12/05/2001
Decision Date 06/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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