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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 K002232
Device Name AEDEFIBRILLATOR
Applicant
MEDICAL RESEARCH LABORATORIES, INC.
1000 ASBURY DR. NO.17
BUFFALO GROVE,  IL  60089
Applicant Contact JOEL ORLINSKY
Correspondent
MEDICAL RESEARCH LABORATORIES, INC.
1000 ASBURY DR. NO.17
BUFFALO GROVE,  IL  60089
Correspondent Contact JOEL ORLINSKY
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
DPS   DRT  
Date Received07/24/2000
Decision Date 12/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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