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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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510(K)
Number
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Decision
Date
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vts-1000 visual testing system NICOLET BIOMEDICAL INSTRUMENTS k812331 11/16/1981
immunogl. frct. of rabbit antiser.-c3 DAKO CORP. k812491 09/23/1981
adult flex float w/heater PHARMAQUEST CORP. k812681 10/08/1981
silastic voice prosthesis DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS k812864 11/24/1981
aburia-ck ria test kit INTL. IMMUNOASSAY LABORATORIES, INC. k813087 12/17/1981
unscented menstrual pads-maxi pads I.C.D. INDUSTRIES, INC. k813251 12/14/1981
nihon kohden heart monitors omp 7101-02 NIHON KOHDEN AMERICA, INC. k813444 12/29/1981
holter performer APPLIED CARDIAC SYSTEMS k813602 01/29/1982
multi-unit, multi-purpose device THE SCOTT & FETZER CO. k813638 05/07/1982
microthin-pi CARDIAC PACEMAKERS, INC. k800027 01/31/1980

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