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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Applicant
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510(K)
Number
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Decision
Date
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modification to carto ep navigation system BIOSENSE WEBSTER, INC. k000190 05/05/2000
modification to cd spinal system MEDTRONIC SOFAMOR DANEK, INC. k000453 03/10/2000
modification to cd spinal system MEDTRONIC SOFAMOR DANEK, INC. k000476 03/10/2000
modification to hermes operating room control center COMPUTER MOTION, INC. k003222 11/03/2000
modification to isobar spinal system ENCORE ORTHOPEDICS, INC. k000020 02/03/2000
modification to kion anesthesia system SIEMENS ELEMA AB k001315 05/26/2000
modification to masimo set radical pulse oximeter with satshare and lnop series of sensors and cables MASIMO CORP. k003244 11/08/2000
modification to mixject dispensing pin/with detachable vial holder/with detachable vial holder and pre-attached needle MEDIMOP MEDICAL PROJECTS, LTD. k001293 05/05/2000
modification to provident hip system STELKAST COMPANY k002796 09/28/2000
modification to softouch diagnostic intravascular cat MERIT MEDICAL SYSTEMS, INC. k000659 03/29/2000

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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