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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 K902429
Device Name MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE
Applicant
Laerdal Mfg. Corp.
12244 SW Garden Pl.
Portland,  OR  97223
Applicant Contact JOHN L KARPOWICZ
Correspondent
Laerdal Mfg. Corp.
12244 SW Garden Pl.
Portland,  OR  97223
Correspondent Contact JOHN L KARPOWICZ
Regulation Number870.5300
Classification Product Code
LDD  
Date Received05/22/1990
Decision Date 09/27/1990
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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