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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 K871978
Device Name CODMAN FLEXIBLE ENDOSCOPE
Applicant
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Applicant Contact THOMAS J COURAGE
Correspondent
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Correspondent Contact THOMAS J COURAGE
Regulation Number876.1500
Classification Product Code
GCQ  
Date Received05/22/1987
Decision Date 08/25/1987
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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