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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K033178
Device Name ULTRABIO
Applicant
SONOTECH, INC.
774 MARINE DR.
BELLINGHAM,  WA  98225
Applicant Contact MARGARET J LARSON
Correspondent
SONOTECH, INC.
774 MARINE DR.
BELLINGHAM,  WA  98225
Correspondent Contact MARGARET J LARSON
Regulation Number892.1570
Classification Product Code
MUI  
Date Received10/01/2003
Decision Date 08/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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