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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, electrosurgical
510(k) Number K000079
Device Name NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
Applicant
NIKOMED U.S.A., INC.
P.O. BOX 560
STILLWATER,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
NIKOMED U.S.A., INC.
P.O. BOX 560
STILLWATER,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number878.4400
Classification Product Code
HAM  
Subsequent Product Code
GEI  
Date Received01/11/2000
Decision Date 02/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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