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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, electrocardiograph
510(k) Number K851732
Device Name CARBOCONE
Applicant
IMTECH CORP.
260 WEST BROADWAY
NEW YORK,  NY  10013
Applicant Contact PAUL NOBLE
Correspondent
IMTECH CORP.
260 WEST BROADWAY
NEW YORK,  NY  10013
Correspondent Contact PAUL NOBLE
Regulation Number870.2360
Classification Product Code
DRX  
Date Received04/25/1985
Decision Date 09/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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