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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Choledochoscope And Accessories, Flexible/Rigid
510(k) Number K935834
Device Name TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE
Applicant
Technology Marketing Group
525 Palmer Ave.
Maywood,  NJ  07607
Applicant Contact THOMAS HYNES, ESQ.
Correspondent
Technology Marketing Group
525 Palmer Ave.
Maywood,  NJ  07607
Correspondent Contact THOMAS HYNES, ESQ.
Regulation Number876.1500
Classification Product Code
FBN  
Subsequent Product Code
FGB  
Date Received12/07/1993
Decision Date 03/07/1994
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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