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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Shunt, Endolymphatic With Valve
510(k) Number K972383
Device Name EASY-JET DEVICE
Applicant
A.Stein - Regulatory Affairs Consulting
P.O.B. 454
Ginot Shomron 44853,  IL 44853
Applicant Contact AHAVA STEIN
Correspondent
A.Stein - Regulatory Affairs Consulting
P.O.B. 454
Ginot Shomron 44853,  IL 44853
Correspondent Contact AHAVA STEIN
Regulation Number874.3850
Classification Product Code
KLZ  
Date Received06/26/1997
Decision Date 11/23/1999
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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