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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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medtronic model 5013 Medtronic Vascular k863536 01/06/1987
mee-1000a neuromaster Nihon Kohden America, Inc. k051178 08/17/2005
mega pericardiocentesis kit Mega Medical, Inc. k912564 09/05/1991
mega plus super lag screw Pfizer Hospital Products Group, Inc. k930156 02/22/1994
megacart Siemens Burdick, Inc. k915225 07/01/1992
meticuly patient-specific titanium maxillofacial mesh implant Meticuly Co., Ltd. k232889 04/30/2024
metronic sofamor danek cement restrictor Medtronic Sofamor Danek, Inc. k011998 07/26/2001
micro mammo i mammography unit Amerasia Import-Export, Inc. k871048 09/01/1987
migwang comfort 38 (polymacon) spherical and toric soft contact lens for daily wear (clear, tinted and cosmetic) Mi Gwang Contact Lens Co., Ltd. k051477 03/10/2006
mini mash 2000 Dynatech Corp. k854602 12/06/1985

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