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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 K063078
Device Name MICROENDOSCOPE
Applicant
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK,  CA  94025
Applicant Contact DEBBIE COGAN
Correspondent
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK,  CA  94025
Correspondent Contact DEBBIE COGAN
Regulation Number874.4760
Classification Product Code
EOB  
Date Received10/10/2006
Decision Date 10/24/2006
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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