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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 K171402
Device Name KARL STORZ Slim Nasopharyngolaryngoscope
Applicant
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
El Segundo,  CA  90245
Applicant Contact AnnaLisa Smullin
Correspondent
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
El Segundo,  CA  90245
Correspondent Contact AnnaLisa Smullin
Regulation Number874.4760
Classification Product Code
EOB  
Date Received05/12/2017
Decision Date 02/02/2018
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
Recalls CDRH Recalls
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