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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scanner, Fluorescent
510(k) Number K900574
Device Name ABIOMED BODY LEAD ANALYZER MODEL 200/20
Applicant
Abiomed, Inc.
33 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact FREDRIC L MILDER
Correspondent
Abiomed, Inc.
33 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact FREDRIC L MILDER
Regulation Number892.1220
Classification Product Code
JAO  
Date Received02/07/1990
Decision Date 03/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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