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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
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Decision
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vitros chemistry products calibrator kit 99, vitros chemistry products aat/hpt performance verifier i, ii, and iii Ortho-Clinical Diagnostics, Inc. k060940 04/24/2006
vpw 2877e6 x-ray power supply Varian Canada, Inc. k910820 03/07/1991
w&h micro motor e25 (without light) A-Dec, Inc. k944712 08/25/1995
wako autokit lp(a)/express 550 Wako Chemicals USA, Inc. k001921 07/23/2000
web ii memory extraction basket or memory ii double lumen extraction basket, memory 5 fr. soft wire baskets or memory helical stone extractor, memory eight wire baskets or memory hard wire baskets, fusion wire guided extraction basket, non-lithotripsy extraction basket Wilson-Cook Medical, Inc. k171969 03/28/2018
wilde light curing composite restorative resins Wilde-USA, Inc. k913089 04/21/1992
windsor medical model 52 Windsor Medical, Inc. k832641 10/04/1983
world knee total knee systems Signature Orthopaedics Pty, Ltd. k190577 11/27/2019
x-view Sometech Corporation k024186 04/01/2004
xenon light source illuminator Stephen Chakoff, Inc. k932631 11/16/1993

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