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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier And Signal Conditioner, Transducer Signal
510(k) Number K050006
Device Name BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO
Applicant
C.R. Bard, Inc.
55 Technology Dr.
Lowell,  MA  01851
Applicant Contact DEBORAH L HERRINGTON
Correspondent
C.R. Bard, Inc.
55 Technology Dr.
Lowell,  MA  01851
Correspondent Contact DEBORAH L HERRINGTON
Regulation Number870.2060
Classification Product Code
DRQ  
Date Received01/03/2005
Decision Date 05/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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