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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K002766
Device Name NICOLET VASOGUARD
Applicant
Nicolet Biomedical
6355 Joyce Dr.
Golden,  CO  80403
Applicant Contact DAVID W WAGNER
Correspondent
Nicolet Biomedical
6355 Joyce Dr.
Golden,  CO  80403
Correspondent Contact DAVID W WAGNER
Regulation Number870.2880
Classification Product Code
JOP  
Date Received09/05/2000
Decision Date 11/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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