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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 K874204
Device Name 450SLL DEFIBRILLATOR
Applicant
Medical Research Laboratories, Inc.
6457 W. Howard St.
Niles,  IL  60648
Applicant Contact DILIP MEHTA
Correspondent
Medical Research Laboratories, Inc.
6457 W. Howard St.
Niles,  IL  60648
Correspondent Contact DILIP MEHTA
Regulation Number870.5300
Classification Product Code
LDD  
Date Received10/15/1987
Decision Date 01/28/1988
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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