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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K960264
Device Name CONMED EKG STRIPPER
Applicant
CONMED CORP.
P.O. BOX 1408
DAYTON,  OH  45401 -1408
Applicant Contact IRA D DUESLER, JR.
Correspondent
CONMED CORP.
P.O. BOX 1408
DAYTON,  OH  45401 -1408
Correspondent Contact IRA D DUESLER, JR.
Regulation Number870.2360
Classification Product Code
DRX  
Date Received01/18/1996
Decision Date 04/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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