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U.S. Department of Health and Human Services

510(K) Premarket Notification

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161 to 170 of 500 Results *
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510(K)
Number
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Decision
Date
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modofication to vitro immunodiagnostic products psa reagent pack, vitro immunodiagnostic products psa calibrators Ortho-Clinical Diagnostics, Inc. k000566 03/09/2000
vitros chemistry products crea slide, virtros chemistry products calibrator kit 1 Ortho-Clinical Diagnostics, Inc. k001310 05/05/2000
multi adjustable face mask ORTHO TECHNOLOGY k000358 06/09/2000
hemisphere modular cup system ORTHO DEVELOPMENT CORP. k000321 04/10/2000
proclude ORTEK THERAPEUTICS, INC. k002989 12/14/2000
vulcan tac probes, model 911xxx ORATEC INTERVENTIONS, INC. k003198 08/29/2001
ois-stand alone diagnostic ultrasound system OPTIMAL IMAGING SYSTEMS, INC. k000034 02/24/2000
omnicare dental implant system OMNICARE DENTAL IMPLANT CENTER k000035 09/28/2001
mri fastsystem retractor system OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. k001339 05/17/2000
olympus au2700 clinical chemistry analyzer OLYMPUS AMERICA, INC. k002982 10/25/2000

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