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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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j hook headgear Northwest Orthodontics, Inc. k771095 06/24/1977
electronic digital bp meter hc 3001 North American Philips Corp. k842486 08/24/1984
7-510-25 hysteromed tubing kit Nortech k931606 01/24/1994
dentoridge(tm) hydroxyylapatite Norian Corp. k882098 06/13/1988
espin system Nlt Spine, Ltd. k133061 11/27/2013
manual wheelchair (syiv100a008) Ningbo Shenyu Medical Equipment Co.,Ltd k252517 10/03/2025
mee-1000a neuromaster Nihon Kohden America, Inc. k051178 08/17/2005
arrhythmia central occ-7101 Nihon Kohden America, Inc. k843287 10/18/1984
nextec fiberoptic illuminator 300 watt xenon Nextec Corp. k921646 05/13/1992
principle component eeg analysis software Neuroconcepts, Inc. k951507 07/14/1995

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