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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 K233449
Device Name Avantik VTM
Applicant
Hanchang Medic Co., Ltd. (Han Chang Medic)
10, Wolsan-Ro 201beon-Gil, Eumbong-Myeon
Asan-Si,  KR 14501
Applicant Contact Hyunsoo Shin
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd., Cuttingsville (9478)
Shrewsbury,  VT  05738
Correspondent Contact Gregory M. Chrysler
Regulation Number866.2390
Classification Product Code
JSM  
Date Received10/20/2023
Decision Date 07/15/2024
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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