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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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endoscopic plication system; eps; plicator NDO SURGICAL, INC. k071553 09/18/2007
entec reflex wand 55, model e4055-01, e4045-01 ARTHROCARE CORP. k000778 05/03/2000
esophageal stethoscope 9 french, esophageal stethoscope 12 french, esophageal stethoscope 18 french, esophageal stethoscope, 24 french DeRoyal Industries, Inc. k193027 04/02/2020
esophyx® z device with serosafuse fasteners and accessories ENDOGASTRIC SOLUTIONS, INC. k160960 05/01/2016
esthetic abutments nobel biocare n1 Nobel Biocare Services AG k220339 09/16/2022
estriol-squibb ria kit E. R. SQUIBB & SONS, INC. k802455 10/31/1980
eva select digital dental imaging system AFP IMAGING CORP. k123419 12/27/2012
exactrac 3rd party, exactrac x-ray 6d 3rd party, exactrac oem BRAINLAB AG k072046 10/17/2007
exaflex impression material G-C INTL. CORP. k812406 10/06/1981
fastouch fixation system VIA SURGICAL LTD. k162252 11/14/2016

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