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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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digital mxr-d flowmeter PORTER INSTRUMENT CO., INC. k062155 11/09/2006
grandio flow try-in VOCO GMBH k062343 11/02/2006
lzi amphetamine-specific oral fluid homogeneous enztme immunoassay: lzi amphetamine oral fluid calibrators and controls Lin-Zhi International, Inc. k063024 10/30/2006
unicem 3M ESPE DENTAL PRODUCTS k062292 10/25/2006
pre' vaginal lubricant INGFERTLITY, LLC k051436 10/13/2006
echelon shoulder coil HITACHI MEDICAL SYSTEMS AMERICA, INC. k062556 10/05/2006
23 mm single-peg patella component BIOMET MANUFACTURING, INC. k061340 09/25/2006
plethora solutions sexual assessment monitor (sam) PLETHORA SOLUTIONS k062042 09/06/2006
dimension vista chemistry 1 calibrator, model kc110 DADE BEHRING, INC. k061838 08/21/2006
leksell gamma knife perfexion, model 715000 ELEKTA INSTRUMENT AB k061941 08/21/2006

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