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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 K990354
Device Name ENDOSHEATH
Applicant
VISION-SCIENCES, INC.
9 STRATHMORE RD.
NATICK,  MA  01760
Applicant Contact PAMELA PAPINEAU
Correspondent
VISION-SCIENCES, INC.
9 STRATHMORE RD.
NATICK,  MA  01760
Correspondent Contact PAMELA PAPINEAU
Regulation Number874.4760
Classification Product Code
EOB  
Date Received02/05/1999
Decision Date 03/31/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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