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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K855082
Device Name DEFIB-PADS
Applicant
CONMED CORP.
310 BROAD ST.
UTICA,  NY  13501 -1203
Applicant Contact WILLIAM W ABRAHAM
Correspondent
CONMED CORP.
310 BROAD ST.
UTICA,  NY  13501 -1203
Correspondent Contact WILLIAM W ABRAHAM
Regulation Number870.5300
Classification Product Code
LDD  
Date Received12/19/1985
Decision Date 03/31/1986
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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