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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K132709
Device Name VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
Applicant
Vr Medical
90 Gaoxin Rd., Zhouzhuang
Kunshan,  CN 215325
Applicant Contact LEE PAN, PHD
Correspondent
Vr Medical
90 Gaoxin Rd., Zhouzhuang
Kunshan,  CN 215325
Correspondent Contact LEE PAN, PHD
Regulation Number868.5260
Classification Product Code
CAH  
Date Received08/29/2013
Decision Date 07/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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