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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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navigus peel away introducer IMAGE-GUIDED NEUROLOGICS, INC. k002330 10/18/2000
profile-er MEDTOX DIAGNOSTICS, INC. k002331 01/17/2001
eeg spike and event detector module EXCEL TECH. LTD. k002332 10/06/2000
biosense webster lasso deflectable circular mapping catheter, model d-1220 BIOSENSE WEBSTER, INC. k002333 08/31/2000
macroporens craniloc MACROPORE BIOSURGERY, INC. k002334 05/02/2001
natural-knee ii system-durasul tibial insert and durasul all-poly patella SULZER ORTHOPEDICS, INC. k002335 10/25/2000
ms104a, newmini ii (ems-ii), model ap-101050t and medtrim (ems-v), model ap-102050t APEX MEDICAL CORP. k002336 07/27/2001
branan medical corporation monitect barbiturates drug screen test BRANAN MEDICAL CORPORATION k002337 11/22/2000
liquiderm liquid adhesive bandage CLOSURE MEDICAL CORP. k002338 01/29/2001
aems v, ems-1000, model ts-140500 and aems vi, ems-1000 plus, model ts-140600 APEX MEDICAL CORP. k002339 08/24/2001

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