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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)
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Decision
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modification to convertors surgical gowns ALLEGIANCE HEALTHCARE CORP. k001189 04/21/2000
modification to depuy c-stem system DEPUY ORTHOPAEDICS, INC. k013350 11/07/2001
modification to ebi spinelink system EBI, L.P. k003764 01/02/2001
modification to hermes operating room control center COMPUTER MOTION, INC. k003222 11/03/2000
modification to intralase 600c laser keratome INTRALASE CORP. k001211 12/04/2000
modification to intuitive surgical stereo view endoscopic system INTUITIVE SURGICAL, INC. k001666 08/24/2000
modification to isobar spinal system ENCORE ORTHOPEDICS, INC. k000020 02/03/2000
modification to liquid glucose (hexokinase) reagent set POINTE SCIENTIFIC, INC. k002199 11/20/2000
modification to masimo set radical pulse oximeter with satshare and lnop series of sensors and cables MASIMO CORP. k003244 11/08/2000
modification to rta retinal thickness analyzer TALIA TECHNOLOGY LTD. k000731 03/31/2000

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