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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 K162410
Device Name TIPCAM 1S 3D System
Applicant
KARL STORZ Endoscopy America, Inc
2151 E.Grand Avenue
El Segundo,  CA  90245
Applicant Contact Winkie Wong
Correspondent
KARL STORZ Endoscopy America, Inc
2151 E.Grand Avenue
El Segundo,  CA  90245
Correspondent Contact Winkie Wong
Regulation Number874.4760
Classification Product Code
EOB  
Subsequent Product Code
GWG  
Date Received08/29/2016
Decision Date 03/02/2017
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
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