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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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apex modular alumina femoral head APEX SURGICAL, LLC. k012918 11/27/2001
gimmi alpha sinuscopes model # e.8282.01/31/71 + e.8284.01/31/71; gimmi alpha bronchoscopes model # e.8189.00/01/02/03 GIMMI GMBH k013731 11/27/2001
cardiovascular array W.L. GORE & ASSOCIATES,INC k013810 11/27/2001
dynarex umbilical cord lamp, models 6833 and 6833-b DYNAREX CORP. k012917 11/28/2001
molded cranial helmet FAIRVIEW ORTHOPEDIC LABORATORY k012920 11/28/2001
drystar, model 4500m AGFA CORP. k012941 11/29/2001
norad, nocturnal oral airway dilator appliance DENNIS R. BAILEY, DDS k013049 11/29/2001
modification to:philips m3000a/m3046a compact portable patient monitor, models philips m3000a/m3046a PHILIPS MEDICAL SYSTEMS, INC. k013427 11/29/2001
micromark ii tissue marker,model c1535 ETHICON ENDO-SURGERY, INC. k013413 12/03/2001
autogenesis automator, model m1000 AUTOGENESIS, INC. k013818 12/05/2001

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