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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name source, carrier, fiberoptic light
510(k) Number K905437
Device Name RIVER MEDICAL MICRODRILL SYSTEM
Applicant
RIVER MEDICAL, INC.
P.O.BOX 30517
MEMPHIS,  TN  38130
Applicant Contact GEORGE MURRAY
Correspondent
RIVER MEDICAL, INC.
P.O.BOX 30517
MEMPHIS,  TN  38130
Correspondent Contact GEORGE MURRAY
Regulation Number874.4350
Classification Product Code
EQH  
Date Received12/04/1990
Decision Date 05/30/1991
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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