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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microbial Nucleic Acid Storage And Stabilization Device
510(k) Number K242820
Device Name Puritan PurSafe Plus 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
Classification Product Code
QBD  
Date Received09/18/2024
Decision Date 05/27/2025
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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