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FDA 510(k) Application Details - K000079
Device Classification Name
Apparatus, Electrosurgical
More FDA Info for this Device
510(K) Number
K000079
Device Name
Apparatus, Electrosurgical
Applicant
NIKOMED U.S.A., INC.
P.O. BOX 560
STILLWATER, MN 55082 US
Other 510(k) Applications for this Company
Contact
ELAINE DUNCAN
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
HAM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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