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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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kodak x-omat m20 processor, model 2 Eastman Kodak Company k792434 01/09/1980
conphar silicone coated foley cath Conphar, Inc. k792111 11/16/1979
scoville-lewis aneurysm clips Codman & Shurtleff, Inc. k791764 10/01/1979
implantable pulse generator pacemaker Intermedics, Inc. k791417 09/04/1979
linde oxygen therapy flowmeters, l33-l34 Union Carbide Corp. k791069 06/27/1979
revised battery charger Vickers America Medical Corp. k790689 05/29/1979
spinal surgery instrumentation Stuart Drug & Surgical Supply, Inc. k782061 03/21/1979
tray, urethral catheterization Snyder Laboratories, Inc. k790272 03/06/1979
nephelrate antiserums 1ga Antibodies, Inc. k781655 11/08/1978
oxygen concentrator Bendix Instruments & Life Support Div k781300 10/16/1978

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