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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K942388
Device Name TAS-(VARIOUS) ULTRATHIN 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 Number874.4680
Classification Product Code
EOQ  
Date Received05/19/1994
Decision Date 08/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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