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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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bp cuff barrier 1081789, bp cuff barrier, plastic coated 1030193 MED TEXTILE, LLC k032568 04/29/2004
matang powder-free polychloroprene patient examination gloves MATANG MFG. SDN. BHD. k032549 09/08/2003
master & frank surgical drapes (sterile) MASTER & FRANK ENTERPRSES CO.LTD. k020393 05/03/2002
mastel 1 folder implantation system MASTEL PRECISION, INC. k022723 12/26/2002
masimo lnop-tf-i resuable transflectance sensor MASIMO CORP. k032551 02/19/2004
physical monitoring registration unit MARYROSE CUSIMANO, PH.D./PHIL REASTON k022719 11/13/2002
mallinckrodt dar ty-care / ty-care exel closed suction system MALLINCKRODT DAR S.R.L. k031997 11/25/2003
mainline maxie hcg urine pregnancy test MAINLINE TECHNOLOGY, INC. k031445 07/01/2003
bclear LUMENIS, INC. k021762 08/23/2002
modification to outback catheter LUMEND, INC. k032298 08/26/2003

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