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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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tbg ria Syncor Intl. Corp. k842167 07/09/1984
electronic digital bp meter hc 3001 North American Philips Corp. k842486 08/24/1984
schiff reagent fuchsin-sulfurous acid E K Ind., Inc. k842919 09/11/1984
arrhythmia central occ-7101 Nihon Kohden America, Inc. k843287 10/18/1984
vico micro surgical instruments Visitec Co. k843592 10/05/1984
deodorant super maxithins body-shaped maxi pads Tambrands, Inc. k843958 11/07/1984
model 493-01 pacing lead Intermedics, Inc. k844263 03/28/1985
avl model 982 electrolyte analyzer Avl Scientific Corp. k844587 01/18/1985
pennine nelaton catheters sizes 5,6,8,10,12,14,16, Pennine Medical , Ltd. k844876 06/05/1985
nephrostomy guidewire sheath American Edwards Laboratories k845047 01/15/1985

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