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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 K965233
Device Name SHARPSITE AC
Applicant
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact DAVID TIMLIN
Correspondent
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Correspondent Contact DAVID TIMLIN
Regulation Number874.4760
Classification Product Code
EOB  
Date Received12/31/1996
Decision Date 04/04/1997
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
Predetermined Change
Control Plan Authorized		 No
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