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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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nsi hexed and non-hexed implant system and immediate loading NORTHERN IMPLANTS, LLC k033171 04/27/2004
lactoscrew screw anchor BIOMET ORTHOPEDICS, INC. k033355 06/30/2004
reprocessed multiple clip appliers CLEAR MEDICAL, INC. k033579 07/11/2005
one coat se bond COLTENE/WHALEDENT INC. k033760 01/23/2004
groshong nxt picc catheters C.R. BARD, INC. k034020 01/21/2004
synthes thoracolumbar spine locking plate (tslp) SYNTHES SPINE k020244 04/22/2002
ultra touch powdered latex examination gloves AR ALLIANCE HEALTHCARE SDN. BHD. k020359 03/06/2002
epy-50 DDC TECHNOLOGIES, INC. k020513 05/16/2002
padpro, model 2502 PADPRO LLC. k020743 05/28/2002
vacurect vacuum constriction device VACURECT MANUFACTURING (PTY) LTD. k020969 06/05/2002

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