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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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Applicant
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510(K)
Number
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Decision
Date
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model 2730 clinical refractometer Vee Gee Scientific, Inc. k941906 01/17/1995
model 5867-12 bipolar low-profile lead Medtronic Vascular k812725 11/16/1981
model 704 Ivy Biomedical Systems, Inc. k912139 03/25/1992
model ah behing-the-ear-hearing aid Dahlberg Electronics, Inc. k821550 06/14/1982
modification to fetal assist Huntleigh Diagnostics , Ltd. k020390 04/19/2002
modified island pin tens disposable electrode Empi k901102 03/23/1990
modified model 5455 disposable surgical cable Medtronic Andover Medical, Inc. k882174 07/22/1988
modified olsen 755/756 switchpens Olsen Electrosurgical, Inc. k884174 10/24/1988
molinea underpads Paul Hartmann Corp. k843402 09/07/1984
mtone evo (mtone evo) M&T S.R.L. k240604 09/20/2024

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