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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 K952085
Device Name DPD DEFIBRILLATOR
Applicant
Medical Research Laboratories, Inc.
1000 Asbury Dr. #17
Buffalo Grove,  IL  60089
Applicant Contact JOEL ORLINSKY
Correspondent
Medical Research Laboratories, Inc.
1000 Asbury Dr. #17
Buffalo Grove,  IL  60089
Correspondent Contact JOEL ORLINSKY
Regulation Number870.5300
Classification Product Code
LDD  
Date Received05/03/1995
Decision Date 06/05/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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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