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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 K993306
Device Name NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
Applicant
PALADIN MEDICAL, INC.
P.O. BOX 560
STILLWATER,  MN  55082 -0560
Applicant Contact ELAINE DUNCAN, M.S.M.E., RAC
Correspondent
PALADIN MEDICAL, INC.
P.O. BOX 560
STILLWATER,  MN  55082 -0560
Correspondent Contact ELAINE DUNCAN, M.S.M.E., RAC
Regulation Number878.4400
Classification Product Code
HAM  
Subsequent Product Code
GEI  
Date Received10/04/1999
Decision Date 11/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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