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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 K031790
Device Name SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
Applicant
VISION-SCIENCES, INC.
5 WHITCOMB AVE.
AYER,  MA  01432
Applicant Contact PAMELA PAPINEAU
Correspondent
VISION-SCIENCES, INC.
5 WHITCOMB AVE.
AYER,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number874.4760
Classification Product Code
EOB  
Date Received06/10/2003
Decision Date 07/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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