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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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powder free latex patient examination gloves with aloe vera and protein content labeling claim of 50 micrograms or less MATANG MFG. SDN. BHD. k012558 09/17/2001
modification to: qwh-420 wrist array coil MRI DEVICES CORP. k013099 09/25/2001
toraysulfone dialyzer TORAY INDUSTRIES (AMERICA), INC. k002512 10/15/2001
mosfet autosense, model tn-rd-60 THOMSON & NIELSEN ELECTRONICS, LTD. k013279 10/18/2001
oxygenator ADJUNCTIVE THERAPEUTICS, INC. k002632 10/25/2001
modification to: stryker navigation system, stryker fluoroscopy system,virtual fluoroscopy STRYKER LEIBINGER k012380 12/03/2001
prosthetic accessories to the iti dental implant system INSTITUT STRAUMANN AG k013798 12/19/2001
fotona dualis, fotona dualis plus FOTONA D.D. k011939 12/27/2001
isobar spinal system SCIEN'TX USA INC. k013447 01/15/2002
modification to ebi omega 21 system EBI, L.P. k014137 01/16/2002

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