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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 K903018
Device Name MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002
Applicant
Medtronic Andover Medical, Inc.
60 Newark St.
Haverhill,  MA  01830
Applicant Contact JANICE PEVIDE
Correspondent
Medtronic Andover Medical, Inc.
60 Newark St.
Haverhill,  MA  01830
Correspondent Contact JANICE PEVIDE
Regulation Number870.5300
Classification Product Code
LDD  
Date Received07/11/1990
Decision Date 12/03/1990
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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