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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coagulator-cutter, endoscopic, unipolar (and accessories)
510(k) Number K003405
Device Name ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO
Applicant
HIGHLAND / MARIETTA, INC.
6155 HEISLEY RD.
MENTOR,  OH  44060
Applicant Contact JOHN NIKSA
Correspondent
HIGHLAND / MARIETTA, INC.
6155 HEISLEY RD.
MENTOR,  OH  44060
Correspondent Contact JOHN NIKSA
Regulation Number884.4160
Classification Product Code
KNF  
Subsequent Product Code
GEI  
Date Received11/01/2000
Decision Date 05/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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