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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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modification to ebi vuelock anterior cervical plate system EBI, L.P. k023133 10/18/2002
modification to ebi omega 21 system EBI, L.P. k014137 01/16/2002
model h44-80 behind the ear hearing MARCON HEARING INSTRUMENTS, INC. k791745 10/30/1979
model cgs tilt seating system for power wheelchairs INVACARE CORP. k001777 07/24/2000
model 656 arrhythmia analyzer DEL MAR AVIONICS k792080 12/04/1979
minitape urethral sling MPATHY MEDICAL DEVICES, LTD. k073646 02/25/2008
mimix mp bone void filler BIOMET, INC. k043280 12/21/2004
micro-processor unit #a3600ac GENERAL ELECTRIC CO. k801762 08/27/1980
mesa spinal system K2M, LLC k052398 12/07/2005
megabeam endocular probe and aspirating endocular probe BIOLITEC MEDICAL DEVICES, INC k113792 01/19/2012

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