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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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Decision
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opus spectrum (a model of opus 20), model 2nd OPUSDENT LTD. k014100 01/08/2002
3d humeral heads SMITH & NEPHEW, INC. k012378 12/13/2001
eye-q (xylofilcon a) soft (hydrophilic) multifocal contact lens for daily wear SOFLEX CONTACT LENS INDUSTRIES LTD. k013469 11/20/2001
adc pediatric AGFA CORP. k012750 11/14/2001
reprocessed stryker arthroscopic shavers ALLIANCE MEDICAL CORP. k012635 11/07/2001
crystal and crystal-care implants system CRYSTAL-SEAL DENTAL IMPLANTS k011502 10/22/2001
the nexgen tmt tibia, models 00-5886-xxyy, 05-120-xxyy-0 IMPLEX CORP. k012866 09/26/2001
sts range , models sts20,sts30,sts40 HUNTLEIGH HEALTHCARE, INC. k012008 09/21/2001
oto-cem OTOTECH, INC. k011338 09/13/2001
mpf acetabular cup PLUS ORTHOPEDICS k011836 09/07/2001

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