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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 K132291
Device Name NAMSA CHEMICAL PROCESS
Applicant
North American Science Assoc., Inc.
6750 Wales Rd.
Toledo,  OH  43619
Applicant Contact JULIE WHEELER
Correspondent
North American Science Assoc., Inc.
6750 Wales Rd.
Toledo,  OH  43619
Correspondent Contact JULIE WHEELER
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received07/23/2013
Decision Date 05/20/2014
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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