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U.S. Department of Health and Human Services

510(K) Premarket Notification

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powdered latex exam gloves, protein labeling (150 microgram or less) PREMIER PATHWAY SDN. BHD. k001327 05/23/2000
introducer sheath NOVASYS MEDICAL, INC. k001328 07/17/2000
intravascular iv set, iv set with burette, extension set LIFEMED OF CALIFORNIA k001329 02/14/2001
sovereign bipolar instruments AESCULAP, INC. k001330 05/30/2000
synergy head/neck coil PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. k001331 06/09/2000
agilent component monitoring system, agilent multi-measurement server and compact portable patient monitor, agilent noni AGILENT TECHNOLOGIES DEUTSCHLAND GMBH k001333 05/17/2000
pinnacle acetabular system DEPUY ORTHOPAEDICS, INC. k001534 06/12/2000
zenith plate system, anterior spinal instrumentation ORTHOTEC, L.L.C. k001535 03/20/2001
inter-op metasul hooded and protrusio acetabular inserts SULZER ORTHOPEDICS, INC. k001536 07/27/2000
renu multiplus multi-purpose solution BAUSCH & LOMB, INC. k001539 07/31/2000

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