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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 K131323
Device Name ECLERIS SINUSCOPE
Applicant
Ecleris USA
57 Lazy Brook Rd.
Monroe,  CT  06468
Applicant Contact RAYMOND J KELLY, IV
Correspondent
Ecleris USA
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact RAYMOND J KELLY, IV
Regulation Number874.4760
Classification Product Code
EOB  
Date Received05/08/2013
Decision Date 06/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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