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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 K921244
Device Name DISPOSABLE PROTECTIVE SHEATH
Applicant
VISION-SCIENCES, INC.
6 STRATHMORE RD.
NATICK,  MA  01760
Applicant Contact ALAN I WEST
Correspondent
VISION-SCIENCES, INC.
6 STRATHMORE RD.
NATICK,  MA  01760
Correspondent Contact ALAN I WEST
Regulation Number874.4760
Classification Product Code
EOB  
Date Received03/16/1992
Decision Date 10/06/1992
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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