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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pacemaker, cardiac, external transcutaneous (non-invasive)
510(k) Number K880932
Device Name MRL PACETTE, 450SLL
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 Number870.5550
Classification Product Code
DRO  
Date Received03/07/1988
Decision Date 12/16/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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