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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Angioscope
510(k) Number K941715
Device Name ULTATHIN FLEXIBLE ENDOSCOPE
Applicant
Technology Marketing Group
525 Palmer Ave.
Maywood,  NJ  07607
Applicant Contact THOMAS HYNES
Correspondent
Technology Marketing Group
525 Palmer Ave.
Maywood,  NJ  07607
Correspondent Contact THOMAS HYNES
Regulation Number876.1500
Classification Product Code
LYK  
Date Received04/07/1994
Decision Date 10/04/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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