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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K820122
Device Name PIONEER II BACK PLATE ELECTRODE
Applicant
LIFE SCIENCE INSTRUMENTATION, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
LIFE SCIENCE INSTRUMENTATION, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.2360
Classification Product Code
DRX  
Date Received01/18/1982
Decision Date 03/01/1982
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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