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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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lumiscope tens model 2000t or apcc 3001 or pain re Lumiscope Co., Inc. k880452 03/24/1988
wallenstein medium slant Hardy Media k880138 03/30/1988
urea broth Acumedia Manufacturers, Inc. k881560 04/18/1988
james tendos (syringe holder) Med-Text Intl. k875297 04/19/1988
paramax iron reagent Baxter Healthcare Corp k881104 04/28/1988
medsurg 7 fr. dual lumen central vein cath system Medsurg Industries, Inc. k880771 05/03/1988
alm surgical lamps Alm Surgical Equipment, Inc. k882613 07/18/1988
harbor central venous catheter Harbor Medical Devices, Inc. k881884 07/28/1988
sterile inhalation water transfer set Intertech Resources, Inc. k882582 09/30/1988
luminbond, bonding and cementation system Scientific Pharmaceuticals, Inc. k883392 10/18/1988

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