FDA 510(k) Application Details - K002766

Device Classification Name Transducer, Ultrasonic

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510(K) Number K002766
Device Name Transducer, Ultrasonic
Applicant NICOLET BIOMEDICAL
6355 JOYCE DR.
GOLDEN, CO 80403 US
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Contact DAVID W WAGNER
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Regulation Number 870.2880

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Classification Product Code JOP
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Date Received 09/05/2000
Decision Date 11/30/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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