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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K954609
Device Name HEARTSTART 911
Applicant
Laerdal Medical Corp.
167 Myers Corners Rd.
Wappingers Falls,  NY  12590
Applicant Contact KENNETH B HERLAND
Correspondent
Laerdal Medical Corp.
167 Myers Corners Rd.
Wappingers Falls,  NY  12590
Correspondent Contact KENNETH B HERLAND
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received10/04/1995
Decision Date 01/04/1996
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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