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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 K842637
Device Name UNIFLOW VENT TUBE
Applicant
RICHARDS MEDICAL CO., INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact ROBERT F GAMES
Correspondent
RICHARDS MEDICAL CO., INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact ROBERT F GAMES
Regulation Number874.3880
Classification Product Code
ETD  
Date Received07/09/1984
Decision Date 10/25/1984
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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