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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 K142034
Device Name 3M STERI-VAC STERILIZER/AERATOR
Applicant
3M COMPANY
3M CENTER, BUILDING 275-SW-06
ST. PAUL,  MN  55144
Applicant Contact MATT MORTENSEN
Correspondent
3M COMPANY
3M CENTER, BUILDING 275-SW-06
ST. PAUL,  MN  55144
Correspondent Contact MATT MORTENSEN
Regulation Number880.6860
Classification Product Code
FLF  
Date Received07/28/2014
Decision Date 01/08/2015
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
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