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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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international model xp behind-the-ear Int'L Hearing Aids, Inc. k873798 10/20/1987
abbott testpack rsv Abbott Laboratories k874127 05/06/1988
revised labeling for tdx barbiturates Abbott Laboratories k874483 11/23/1987
tracker-25 infusion catheter Target Therapeutics k874751 02/12/1988
dey-pak purified water, usp, sterile Dey Laboratories, Inc. k875011 01/22/1988
civco seed implant needle guide CIVCO Medical Instruments Co., Inc. k875241 04/14/1988
effervescent denture cleanser Perrigo Co. k880068 03/07/1988
wako(tm) autokit albumin Wako Chemicals USA, Inc. k880313 03/24/1988
laseguide 600a, 600b, 400a, 400b for pulmonary use Laser Peripherals, LLC k880592 04/25/1988
ebv-vca igg antibody test system (enzyme) Immuno Concepts, Inc. k880885 08/30/1988

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