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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K221157
Device Name JR Medic
Applicant
JR Engineering & Medical Technologies (M) SDN.BHD.
Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah 3A/1,
Pusat Perindustrian 2,
Hulu Selangor,  MY 44200
Applicant Contact Ganesan Subramaniam
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZC  
Date Received04/21/2022
Decision Date 08/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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