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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 K170285
Device Name AED Sinuscope
Applicant
National Advanced Endoscopy Devices, Inc.
22134 Sherman Way
Canoga Park,  CA  91303
Applicant Contact Gayle Butler
Correspondent
National Advanced Endoscopy Devices, Inc.
22134 Sherman Way
Canoga Park,  CA  91303
Correspondent Contact Gayle Butler
Regulation Number874.4760
Classification Product Code
EOB  
Date Received01/30/2017
Decision Date 08/01/2017
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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