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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 K933247
Device Name PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS
Applicant
Vision-Sciences, Inc.
6 Strathmore Rd.
Natick,  MA  01760
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Vision-Sciences, Inc.
6 Strathmore Rd.
Natick,  MA  01760
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number874.4760
Classification Product Code
EOB  
Date Received07/02/1993
Decision Date 11/22/1993
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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