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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K200252
Device Name Getinge Assured MI Steam Migrating Integrator
Applicant
Steritec Products Mfg Co, Inc.
74 Inverness Dr. E.
Engelwood,  CO  80112
Applicant Contact Jonathan Rutigliano
Correspondent
Steritec Products Mfg Co, Inc.
74 Inverness Dr. E.
Engelwood,  CO  80112
Correspondent Contact Jonathan Rutigliano
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received02/03/2020
Decision Date 05/21/2020
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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