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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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single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
card guard personal electrocardiogram transmitter, model cg-6206/6306 CARD GUARD SCIENTIFIC SURVIVAL, LTD. k000225 02/11/2000
protege wheelchair OTTO BOCK ORTHOPEDIC INDUSTRY, INC. k000602 03/03/2000
sterltech water purifier STERLTECH, INC. k000941 04/06/2000
control plasma n DADE BEHRING, INC. k001256 05/24/2000
trepchek treponemal antibody eia PHOENIX BIOTECH CORP. k001552 10/19/2000
aaron 1250 high frequency electrosurgical generator, model a1250 AARON MEDICAL INDUSTRIES k001955 12/22/2000
jms apheresis needle set accordion type JMS CO., LTD. k002394 09/05/2001
curon control module electrosurgical generator and accessories, model s500-st CURON MEDICAL, INC. k002898 10/17/2000
bioteque vaginal dilator BIOTEQUE AMERICA, INC. k003380 01/29/2001

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