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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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ls family of co2 lasers including: ls-15 laser system (15 watt) and ls-25 laser system (25 watt) SANDSTONE MEDICAL TECHNOLOGIES, LLC k040563 10/08/2004
herculon soft tissue reattachment system UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC k040594 03/31/2004
rapid aid instant disposable infant heel warmer RAPID AID LTD. k040856 05/03/2004
modification to e-scan xq mri system ESAOTE S.P.A. k041145 05/14/2004
sinon sn-l402 lightweight wheelchair SINON CORPORATION k041465 07/23/2004
shimadzu mobile x-ray system mux-100d series SHIMADZU CORP. k041763 07/13/2004
arthrex humeral fracture plates and screws ARTHREX, INC. k041965 09/08/2004
promedical surgical drapes PROMEDICAL PRODUCTS CO., LTD. k042131 12/10/2004
unicryl m UNITED MEDICAL INDUSTRIES CO. LTD. k042285 12/10/2004
ivent 201 portable ventilator VERSAMED MEDICAL SYSTEMS, INC. k042468 11/17/2004

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