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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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koala clamp MATERNUS, INC. k010695 05/03/2001
master & frank surgical gowns (sterile) MASTER & FRANK ENT. CO., LTD. k012186 12/07/2001
masimo set radical pulse oximeter with satshare and masimo series of sensors and cables MASIMO CORP. k012992 10/03/2001
validate chem 8 calibration verification test set; model 108 MAINE STANDARDS CO. k020450 03/21/2002
lunapads LUNAPADS INTERNATIONAL PRODUCTS LTD k010986 06/13/2001
patient ventilation oxygen concentrating system (pvocs) LITTON SYSTEMS, INC. k013223 02/11/2002
pre-loaded ultrafix rc LINVATEC CORP. k013553 12/19/2001
tai-chi acupuncture needles LHASA MEDICAL, INC. k003760 02/06/2001
lyra g series surgical laser system (sl series q-switched nd:yag configuration) LASERSCOPE k003765 03/06/2001
lares research sunlase 800p laser system (to be sold as pocketpro or pocketpro s4) LARES RESEARCH, INC. k011960 12/21/2001

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