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FDA 510(k) Application Details - K033178
Device Classification Name
Media,Coupling,Ultrasound
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510(K) Number
K033178
Device Name
Media,Coupling,Ultrasound
Applicant
SONOTECH, INC.
774 MARINE DR.
BELLINGHAM, WA 98225 US
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Contact
MARGARET J LARSON
Other 510(k) Applications for this Contact
Regulation Number
892.1570
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Classification Product Code
MUI
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More FDA Info for this Product Code
Date Received
10/01/2003
Decision Date
08/04/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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