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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)
Number
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Decision
Date
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fastpack calibrators Qualigen, Inc. k003096 11/30/2000
eyereve (hioxifilcon d) soft (hydrophilic) contact lens for daily wear Vision Science Co., Ltd. k161124 08/26/2016
extension tube pump set Churchill Corp. k871085 06/15/1987
exactrac dynamic (2.0); exactrac dynamic surface Brainlab AG k240431 07/24/2024
ethibond excel valve loop suture ETHICON, Inc. k003070 11/07/2000
estriol kit Cambridge Nuclear Corp. k811380 06/09/1981
estradiol maia ria kit magnetic separation phase Serono Diagnostics, Inc. k861361 06/27/1986
essex aspiration/irrigation instrument with positioning guide, model sy-1400 Guidant Corporation, Cardiac Surgery k023630 02/20/2003
epi-derm silicone gel sheeting Biodermis Corp. k003948 01/29/2001
entec reflex wand 55, model e4055-00 Arthrocare Corp. k000036 02/04/2000

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