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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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cleartemp ULTRADENT PRODUCTS, INC. k111017 06/06/2011
sterrad (r) cyclesure (r) 24 biological indicator ADVANCED STERILIZATION PRODUCTS k111375 09/14/2012
dp-50 digital ultrasonic diagnostic imaging system SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD k111435 07/08/2011
comprehensive segmental revision system (srs) BIOMET, INC. k111746 12/15/2011
infusite needleless acces device (sterile, bulk non-sterile) and infusite needleless access device 'y' adapter (bulk... RX DEVICES LLC k112073 04/11/2012
quidel molecular influenza a + b assay QUIDEL CORP. k112172 12/22/2011
lifecell tissue expander LIFECELL CORP. k112534 08/10/2012
powderfree polyisoprene surgical gloves PT. MEDISAFE TECHNOLOGIES k112654 02/17/2012
delta tt cups, delta tt liners, bone screws LIMACORPORATE S.P.A. k112898 12/21/2012
em50 self monitoring blood glucose system EPS BIO TECHNOLOGY CORP. k113243 03/28/2012

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