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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K936257
Device Name ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3
Applicant
Mitsubishi Cable America, Inc.
525 Palmer Ave.
Maywood,  NJ  07607
Applicant Contact THOMAS HYNES, ESQ
Correspondent
Mitsubishi Cable America, Inc.
525 Palmer Ave.
Maywood,  NJ  07607
Correspondent Contact THOMAS HYNES, ESQ
Regulation Number874.4760
Classification Product Code
EOB  
Date Received12/30/1993
Decision Date 03/24/1994
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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