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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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link dynamic staple Link America, Inc. k853704 01/21/1986
cpap blower American Air & Process, Inc. k853944 11/21/1985
in vitro test determination of theophylline Clinical Data, Inc. k854183 12/19/1985
dinamap vital signs monitor model 8100 Critikon Company, LLC k854434 05/16/1986
vega dental operating light Alpine Dental Equipment Co. k854646 03/06/1986
max-i-grasp Euro-Med Intl. k854897 05/02/1986
delfia tm hlh kit Lkb Instruments, Inc. k855173 02/28/1986
cefaclor 30 mcg sensitivity discs Difco Laboratories, Inc. k855206 01/24/1986
enzymatic alpha-amylase reagent kit Bio-Analytics Laboratories, Inc. k860245 03/14/1986
standard wheelchairs Formotion, Inc. k860521 03/10/1986

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