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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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occu-flo punctum plugs U.S. IOL, INC. k001768 09/19/2000
vitros chemistry products crea dt slides; vitros chemistry products dt calibrator kit ORTHO-CLINICAL DIAGNOSTICS k001769 06/21/2000
bci m4529a oem digital handheld oximeter, model m4529a BCI, INC. k001770 07/05/2000
ifa kit for the detection of endomysial iga anibodies using primate umbilical cord (puc)-ema/puc lga. SCIMEDX CORP. k002107 08/04/2000
oleeva foam BIO MED SCIENCES, INC. k002109 08/31/2000
spl crimp system PIONEER SURGICAL TECHNOLOGY k002110 10/06/2000
rubbercare polymer-coated powdered latex examination gloves/guardian polymer-coated powdered examination gloves. contai PERUSAHAAN PELINDUNG GETAH (M) SDN BHD k002111 09/08/2000
rubbercare polymer-chlorinated powder-free guardian polymer-chlorinated powder-free PERUSAHAAN PELINDUNG GETAH (M) SDN BHD k002112 08/14/2000
ctxa hip; ctxa; qct pro ctxa hip MINDWAYS SOFTWARE, INC. k002113 12/04/2001
rubbercare guardian polymer-coated powder-free latex examination gloves: contains 100 micrograms or less of total water PERUSAHAAN PELINDUNG GETAH (M) SDN BHD k002114 08/11/2000

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