FDA 510(k) Application Details - K000079

Device Classification Name Apparatus, Electrosurgical

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510(K) Number K000079
Device Name Apparatus, Electrosurgical
Applicant NIKOMED U.S.A., INC.
P.O. BOX 560
STILLWATER, MN 55082 US
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Contact ELAINE DUNCAN
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Regulation Number 878.4400

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Classification Product Code HAM
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Date Received 01/11/2000
Decision Date 02/04/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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