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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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elecsys b-crosslaps calcheck Roche Diagnostics Corp. k000042 03/17/2000
elecsys anti-tpo calcheck Roche Diagnostics Corp. k001014 06/01/2000
ekg transmitter model 5134 Instromedix, Inc. k842051 03/01/1985
eeg spike and event detector module Excel Tech. , Ltd. k002332 10/06/2000
econo mate Mountain Medical Equipment, Inc. k843715 10/10/1984
easyfit silkgel nasal mask Weinmann Gerate Fur Medizin GmbH + Co. KG k110884 07/12/2011
easy-test creatinine (crea) item no. 19009 Em Diagnostic Systems, Inc. k874088 11/06/1987
easistim Promed Corp. k861091 06/02/1986
earlysense (everon) system Earlysense, Ltd. k120465 06/08/2012
earette hearing aid(behing the ear) Oticon Corp. k810576 03/17/1981

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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