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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Flexible
510(k) Number K920979
Device Name CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340)
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 Number876.1500
Classification Product Code
GCQ  
Date Received03/02/1992
Decision Date 03/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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