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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 K031894
Device Name SCANTEC PAD
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 Received06/19/2003
Decision Date 07/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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