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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K031128
FOIA Releasable 510(k) K031128
Device Name B-SMART, MODEL B-01
Applicant
MACOSTA MEDICAL USA, LLC
5 WHITCOMB AVENUE
AYER,  MA  01432
Applicant Contact PAMELA PAPINEAU
Correspondent
MACOSTA MEDICAL USA, LLC
5 WHITCOMB AVENUE
AYER,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received04/09/2003
Decision Date 01/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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