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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 K100125
Device Name VISION SCIENCES FLEXIBLE ENT SCOPE
Applicant
Vision-Sciences, Inc.
40 Ramland Rd. S.
Orangeburg,  NY  10962
Applicant Contact LILLIAN QUINTERO
Correspondent
Vision-Sciences, Inc.
40 Ramland Rd. S.
Orangeburg,  NY  10962
Correspondent Contact LILLIAN QUINTERO
Regulation Number874.4760
Classification Product Code
EOB  
Date Received01/19/2010
Decision Date 02/25/2010
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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