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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Propagating Transport
510(k) Number K142366
Device Name Puritan OptiTranz Liquid Stuart Collection and Transport System
Applicant
Puritan Medical Products, LLC
31 School St., P.O. Box 149
Guilford,  ME  04443
Applicant Contact Mehdi Karamchi
Correspondent
Puritan Medical Products, LLC
31 School St., P.O. Box 149
Guilford,  ME  04443
Correspondent Contact Mehdi Karamchi
Regulation Number866.2390
Classification Product Code
JSM  
Subsequent Product Codes
JTW   LIO  
Date Received08/25/2014
Decision Date 01/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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