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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Applicant
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510(K)
Number
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Decision
Date
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modification to: total intact pth immunochemiluminometric (icma) assay kit SCANTIBODIES LABORATORY, INC. k060348 02/27/2006
belimed steam sterilizer top 5000, model 5-5-9 SAUTER AG k060337 03/08/2006
sanarus cassi ii rotational core biopsy system, model cs2000 SANARUS MEDICAL, INC. k051581 07/27/2005
modification to: tamper evident ultrasafe passive delivery system, ultrasafe passive delivery system (x-series) SAFETY SYRINGES, INC. k060743 04/28/2006
thermotek q5 SAAT LTD. k041646 07/22/2004
rubicor encapsule breast biopsy device, model 31108 RUBICOR MEDICAL, INC. k052506 10/06/2005
interplate vbr system RSB SPINE LLC. k061401 08/18/2006
rossmax automatic blood pressure monitor model mo701k ROSSMAX INTERNATIONAL LTD. k060342 04/04/2006
see-it caries detector RONVIG DENTAL MFG. A/S k060330 04/07/2006
embryon gift transfer catheters/sets ROCKET MEDICAL PLC k000656 03/09/2000

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