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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 K970247
Device Name SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
Applicant
SMITH & NEPHEW, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Applicant Contact DEBORAH J CONNORS
Correspondent
SMITH & NEPHEW, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Correspondent Contact DEBORAH J CONNORS
Regulation Number874.4760
Classification Product Code
EOB  
Date Received01/22/1997
Decision Date 03/21/1997
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
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