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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 K031222
Device Name SCANLUBE
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 Received04/17/2003
Decision Date 07/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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