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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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mediplus single use gi manometry catheter MEDIPLUS LTD. k013704 08/05/2002
act iii ventricular catheter INNERSPACE, INC. k013705 09/09/2002
softique, model gi 11001 GLOBAL TV CONCEPTS, LTD. k013707 02/01/2002
reference check, catalog number-rcn-10 PRECISION BIOLOGIC k013708 12/10/2001
hill-rom primaview monitor system HILL-ROM, INC. k013709 11/16/2001
bacti-swab dry REMEL CO. k013711 11/26/2001
enteryx injector ENTERIC MEDICAL TECHNOLOGIES k013712 05/31/2002
arm automatic reprocessing machine ALCAVIS INTERNATIONAL INCORPORATED k013713 07/15/2002
codan us i.v. administration set, model b400 sp CODAN US CORP. k013714 03/28/2002
re-usable sterilization pouch / bag QUALITY PRODUCTS OF MONTANA k013715 04/01/2002

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