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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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test kit, iif-ana MEDICA CORP. k782048 01/17/1979
analyzer, model cc-720 SYSMEX CORP. k790026 02/08/1979
tinnitus maskers model s584 VICAN INSTRUMENT CO. k790190 02/12/1979
ultrasonic diagnostic system HOFFREL INSTRUMENTS, INC. k790396 03/21/1979
pacemaker, ovalith-d cardiac CARATOMIC k790566 03/19/1979
emit-tox serum benzodiazepine assay SYVA CO. k790736 04/26/1979
emit auto digoxin assay SYVA CO. k790937 06/15/1979
wrench TRUTH, INC. k791073 06/20/1979
pyrolite carbon endosseous dental impl CARBOMEDICS, INC. k791237 08/28/1979
sponge counter bags MEDICARE INDUSTRIES, INC. k791434 10/09/1979

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