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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 K855247
Device Name INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER
Applicant
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Applicant Contact DONALD A LINCOLN
Correspondent
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Correspondent Contact DONALD A LINCOLN
Regulation Number892.1570
Classification Product Code
ITX  
Date Received12/23/1985
Decision Date 02/19/1987
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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