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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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hydragel iso-pal k20 (pn 3022); hydragel 7 iso-pal (pn 4112); hydragel 15 iso-pal (pn 4132) SEBIA k011113 06/13/2001
etymotic research er-10d oae probe ETYMOTIC RESEARCH k011114 07/03/2001
kurz upper eyelid implant- platinum/iridium,models regular 4007 003-007, special 4007 002, 4007 008-010 HEINZ KURZ GMBH MEDIZINTECHNIK k011115 05/02/2001
pasco mic and mic/id panels inclusion of esbl confirmatory test PASCO LABORATORIES, INC. k011116 04/24/2001
mps acacia medflo infusion (li) and mps acacia medflo infusion (li) keep vein open (kvo) elastomeric pumps MPS ACACIA k011117 07/09/2001
normed extremity titanium hand and small fragment system OSTEOMEDICS k011118 07/20/2001
brachyseed pd-103 models #pd1 DRAXIMAGE, INC. k011119 06/25/2001
glucopro infusion set, model gpisxxxxxxxx series NIPRO DIABETES SYSTEMS, INC. k011120 05/08/2001
rusch percutaneous nephrostomy catheter sets RUSCH INTL. k011121 11/16/2001
ballpen spinal needle w/wo introducer RUSCH INTL. k011122 11/16/2001

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