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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 K181434
Device Name SporView Rapid Read Biological Indicator SteamPlus Test Pack
Applicant
Crosstex/Spsmedical, A Division of Cantel Medical
6789 W. Henrietta Rd.
Rush,  NY  14543
Applicant Contact Megan Skaar
Correspondent
Crosstex/Spsmedical, A Division of Cantel Medical
6789 W. Henrietta Rd.
Rush,  NY  14543
Correspondent Contact Megan Skaar
Regulation Number880.2800
Classification Product Code
FRC  
Date Received06/01/2018
Decision Date 11/14/2018
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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