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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tympanostomy
510(k) Number K904597
Device Name GROMMET STYLE VENTURI
Applicant
RIVER MEDICAL, INC.
P.O.BOX 30517
MEMPHIS,  TN  38130
Applicant Contact W MURRAY
Correspondent
RIVER MEDICAL, INC.
P.O.BOX 30517
MEMPHIS,  TN  38130
Correspondent Contact W MURRAY
Regulation Number874.3880
Classification Product Code
ETD  
Date Received10/10/1990
Decision Date 01/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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