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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Display, Cathode-Ray Tube, Medical
510(k) Number K760721
Device Name MEDICAL OSCILLOSCOPE MEMORY SCOPE
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Regulation Number870.2450
Classification Product Code
DXJ  
Date Received09/27/1976
Decision Date 10/06/1976
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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