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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K953468
Device Name SONOGEL
Applicant
Sonotech, Inc.
1413 Fraser St.
Bldg. H, Suite 102
Bellingham,  WA  98226
Applicant Contact MARGARET J LARSON
Correspondent
Sonotech, Inc.
1413 Fraser St.
Bldg. H, Suite 102
Bellingham,  WA  98226
Correspondent Contact MARGARET J LARSON
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/24/1995
Decision Date 10/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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