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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K163144
Device Name gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
Applicant
Gke-GmbH
Auf Der Lind 10
Waldems,  DE 65529
Applicant Contact Ulrich Kaiser
Correspondent
Gke-GmbH
Auf Der Lind 10
Waldems,  DE 65529
Correspondent Contact Ulrich Kaiser
Regulation Number880.2800
Classification Product Code
FRC  
Date Received11/09/2016
Decision Date 04/07/2017
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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