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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 K844447
Device Name M/D4 W/CHARGER (CARDIOPAC 3M11)
Applicant
Datascope Corp.
580 Winters Ave.
P.O. Box 5
Paramus,  NJ  07653
Applicant Contact HAL SUMNER
Correspondent
Datascope Corp.
580 Winters Ave.
P.O. Box 5
Paramus,  NJ  07653
Correspondent Contact HAL SUMNER
Regulation Number870.5300
Classification Product Code
LDD  
Date Received11/16/1984
Decision Date 01/14/1985
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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