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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
Contact charles o hancock
Regulation Number880.6860
Classification Product Code
FLF  
Date Received12/05/2001
Decision Date 06/25/2003
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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