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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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serum clonazepam toxicology control Utak Laboratories, Inc. k862421 11/05/1986
the saver kit Myocure, Inc. k863666 10/20/1986
model 10-c w/fl-10a/u for surgery and dermatology Directed Energy, Inc. k862862 09/19/1986
meadow fescue allergen disc Immuno Nuclear Corp. k863098 09/15/1986
ceryx pacemaker models 114, 314 & 614 Vitatron Medical BV k854790 08/28/1986
cobalt, 29.5% chromium alloy dental bake-on alloy Austenal Dental, Inc. k862667 07/31/1986
port-a-trac Port-A-Trac Co. k861554 06/19/1986
raichem amylase reagent Reagents Applications, Inc. k861269 05/29/1986
gentamicin sulfate solution (50mg gentamicin) Flow Laboratories, Inc. k861823 05/20/1986
right atrial catheter catalog no. rac - xxx series Intracath, Inc. k860699 04/02/1986

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