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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K882174
Device Name MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE
Applicant
Medtronic Andover Medical, Inc.
60 Newark St.
Haverhill,  MA  01830
Applicant Contact EDWARD SHAUGHNESSY
Correspondent
Medtronic Andover Medical, Inc.
60 Newark St.
Haverhill,  MA  01830
Correspondent Contact EDWARD SHAUGHNESSY
Regulation Number870.2900
Classification Product Code
DSA  
Date Received05/18/1988
Decision Date 07/22/1988
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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