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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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medline sterilization wrap MEDLINE INDUSTRIES, INC. k002968 01/23/2001
xltek evoked potential headbox, model ep-8 XLTEK k002969 12/08/2000
subdural evacuating port system, model 11-9901 MEDICAL DESIGNS L.L.C. k002970 12/12/2000
mtg - minitub heated stage systems ZANDER MEDICAL SUPPLIES, INC. k002971 12/15/2000
merogel control gel ent surgical dressing MEDTRONIC XOMED k002972 12/15/2000
embol-x introducer, model cf00200 EMBOL-X, INC. k002973 04/26/2001
emit tox acetaminophen assay, model 7a319ul; emit tox ecetaminophen calibrators, model 7a409ul DADE BEHRING, INC. k002974 10/11/2000
dermagrip powder free polymer coated latex examination glove sterile, contains 50 micrograms or less of total extractabl WRP SPECIALTY PRODUCTS SDN. BHD. k002975 10/24/2000
response electrophysiology catheter, supreme electrophysiology catheter, model 401xxx and 401xxx ST. JUDE MEDICAL k002976 12/22/2000
ligthspeed 3.0 ct scanner system GE MEDICAL SYSTEMS k002978 10/10/2000

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