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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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pediatric reference data LUNAR CORP. k001812 07/10/2000
synamps (32-64 channels), esi synamps (65-128 channels), esi synamps (129-256 channels) NEURO SCAN LABS k001324 07/11/2000
needleless transfer device MEDIMOP MEDICAL PROJECTS, LTD. k001831 07/11/2000
nitrile examination gloves, pre-powdered, color blue SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. k001837 07/11/2000
19 ga plastic reinforced epidural catheter ARROW INTL., INC. k001587 07/12/2000
island biosurgical bns kit #3 ISLAND BIOSURGICAL, LLC. k001583 07/13/2000
spinal cord and immobilization traction system CAVENDISH SCOTT, INC. k001296 07/17/2000
introducer sheath NOVASYS MEDICAL, INC. k001328 07/17/2000
liberty 9000 breast coil with disposable biopsy plate USA INSTRUMENTS, INC. k001582 07/17/2000
j.a.g. lightweight manual wheelchair ROLL-ABILITY (PTY) LTD. k001298 07/18/2000

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