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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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bacttrap Pharma Systems, Inc. k903056 11/05/1990
allergy control covers Allergy Control Products, Inc. k903382 11/02/1990
a-port implantable vascular access system line ex. Therex Corp. k903691 10/12/1990
trojan(r) extra str latex condom w/sperm sili lubr Armkel, LLC k904000 02/19/1991
local report generator Spacelabs, Inc. k904318 12/18/1990
new cobe centrysystem(tm) 100 hg dialyzer Cobe Laboratories, Inc. k904566 12/12/1990
respironics' digital manometer Respironics, Inc. k904935 04/03/1991
vesseloops Sparta Surgical Corp. k905240 02/06/1991
berlex bolus/infusion(tm) intravenous admin set Venusa , Ltd. k905518 06/21/1991
combo fetal scalp electrode/legplate Utah Medical Products, Inc. k905830 03/29/1991

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