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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 K181788
Device Name Lead-free Chemical Indicators for Steam Sterilization
Applicant
Kem Medical Products Corp.
400 Broadhollow Rd., Suite 2
Farmingdale,  NY  11735
Applicant Contact Douglas A. Kruger
Correspondent
Kem Medical Products Corp.
400 Broadhollow Rd., Suite 2
Farmingdale,  NY  11735
Correspondent Contact Douglas A. Kruger
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received07/05/2018
Decision Date 03/01/2019
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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