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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K925081
Device Name SURFAS
Applicant
D.O. Weaver and Co.
565-C Nucla Way
Aurora,  CO  80011
Applicant Contact DOUGLAS T CLEVELAND
Correspondent
D.O. Weaver and Co.
565-C Nucla Way
Aurora,  CO  80011
Correspondent Contact DOUGLAS T CLEVELAND
Regulation Number892.1570
Classification Product Code
ITX  
Date Received10/07/1992
Decision Date 09/28/1993
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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