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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
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ubit-ir300 infrared spectrometry system OTSUKA PHARMACEUTICAL CO., LTD. k013371 12/21/2001
opus spectrum (a model of opus 20), model 2nd OPUSDENT LTD. k014100 01/08/2002
mark 5000 quadrature shoulder coil USA INSTRUMENTS, INC. k013854 02/06/2002
cardiovention corx system, model fg 0001 CARDIOVENTION, INC. k012325 04/09/2002
diasol-bicarb DIASOL, INC. k020230 04/23/2002
palomar estelux pulsed light system and palomar coolroller PALOMAR MEDICAL TECHNOLOGIES, INC. k020453 05/10/2002
latex surgeons glove (powder free) BRIGHTWAY GLOVES PVT. LTD. k014283 05/22/2002
finesun ems stimulator FINESUN WORLDWIDE INTL. CO., LTD. k020684 05/23/2002
biotouch massage therapy system TACTILE SYSTEMS TECHNOLOGY INC k013061 07/01/2002
primechair DALTON MEDICAL CORP. k021199 07/12/2002

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