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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 K812520
Device Name 280/4 MINI-DEFIBRILLATOR
Applicant
LIFE SCIENCE INSTRUMENTATION, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LIFE SCIENCE INSTRUMENTATION, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.5300
Classification Product Code
LDD  
Date Received09/02/1981
Decision Date 09/25/1981
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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