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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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Decision
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ohmeda inovent delivery system OHMEDA MEDICAL den000001 01/11/2000
nikopad electrosurgical grounding pad, model 4777m NIKOMED U.S.A., INC. k000079 02/04/2000
cbyon surgical operating system (sos) CBYON, INC. k000171 03/13/2000
immulite 2000 pap, models l2kpa2, l2kpa6 DIAGNOSTIC PRODUCTS CORP. k000257 02/23/2000
opti-free express lens drops ALCON UNIVERSAL, LTD. k000385 04/28/2000
accuclot drvvt screen, catalog no. a6094 SIGMA DIAGNOSTICS, INC. k000527 04/07/2000
pectofix dynamic sternal fixation system (dsf) PECTOFIX, INC. k000694 05/11/2000
ac powered thermal cautery unit STARION INSTRUMENTS k000893 06/14/2000
vitro chemistry products eco2 slide & calibrator kit 2 Ortho-Clinical Diagnostics, Inc. k001133 04/24/2000
protector 21, protector 50, protector 14, injector luer lock, infusion adapter CARMEL PHARMA AB. k001368 05/12/2000

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