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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K132174
Device Name MULTICHEM WBT
Applicant
Techno-Path Manufacturing , Ltd.
325 Big Elm St.
Highland Village,  TX  75077
Applicant Contact STEPHANIE G GARTH
Correspondent
Techno-Path Manufacturing , Ltd.
325 Big Elm St.
Highland Village,  TX  75077
Correspondent Contact STEPHANIE G GARTH
Regulation Number862.3280
Classification Product Code
DIF  
Date Received07/15/2013
Decision Date 09/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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