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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 K003830
Device Name ENT ENDOSCOPES
Applicant
GLOBAL ENDOSCOPY, INC.
914 W. ESTES CT.
SCHAUMBURG,  IL  60193 -4426
Applicant Contact NICK MIRCEA
Correspondent
GLOBAL ENDOSCOPY, INC.
914 W. ESTES CT.
SCHAUMBURG,  IL  60193 -4426
Correspondent Contact NICK MIRCEA
Regulation Number874.4760
Classification Product Code
EOB  
Date Received12/11/2000
Decision Date 04/09/2001
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
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