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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 K900881
Device Name OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM
Applicant
Codman & Shurtleff, Inc.
C/O Medical Device Consultants
45 W. St., Suite 2
Attleboro,  MA  02703
Applicant Contact JAMES R VEALE
Correspondent
Codman & Shurtleff, Inc.
C/O Medical Device Consultants
45 W. St., Suite 2
Attleboro,  MA  02703
Correspondent Contact JAMES R VEALE
Regulation Number892.1560
Classification Product Code
IYO  
Date Received02/26/1990
Decision Date 09/25/1990
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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