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FDA 510(k) Application Details - K040840
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K040840
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
TERATECH CORP.
PO BOX 10074
13221 NE TEEM LOOP ROAD
BAINBRIDGE ISLAND, WA 98110 US
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Contact
CHARLES F HOTTINGER
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Regulation Number
892.1570
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Classification Product Code
ITX
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More FDA Info for this Product Code
Date Received
04/01/2004
Decision Date
04/14/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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