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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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kimax, model 1024 MEDICAL METRICS, INC. k010187 02/14/2001
bd eclipse hypodermic needle BD MEDICAL SYSTEMS k010188 03/01/2001
vortex access system HORIZON MEDICAL PRODUCTS, INC. k010189 02/12/2001
wristwatch blood pressure monitor, model a43 ROSSMAX INTERNATIONL LTD. k010190 02/08/2001
y2000 pocket rescue CHEEN HOUNG ENT. CO. LTD. k010191 03/14/2001
endoscopic tube shaft instruments for monoplar coagulation ANTYLLOS MEDIZINTECHNIK GMBH k010192 04/02/2001
hemochron kaolin-activated heparin and protamine dosing assays INTERNATIONAL TECHNIDYNE CORP. k010193 06/06/2001
comfor-cliner RECLINER CARE, INC. k010194 02/15/2001
premier ultrasonic scaler and inserts PREMIER DENTAL PRODUCTS CO. k010195 04/17/2001
total cure BISCO, INC. k010196 04/05/2001

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