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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K261266
Device Name MOWANA™ Auto Duo
Applicant
PENTAMASTER MEDIQ SDN BHD
Pmt 861, Persiaran Cassia Selatan 6
Simpang Ampat,  MY 14110
Applicant Contact Thean Lye Ong
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact Dave Yungvirt
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/16/2026
Decision Date 09/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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