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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K925008
Device Name RLN NERVE LOCATOR/MONITOR; MODEL A
Applicant
RLN SYSTEMS, INC.
2019 HONEYSUCKLE LN.
P.O. BOX 6757
JEFFERSON CITY,  MO  65109
Applicant Contact LEE REA
Correspondent
RLN SYSTEMS, INC.
2019 HONEYSUCKLE LN.
P.O. BOX 6757
JEFFERSON CITY,  MO  65109
Correspondent Contact LEE REA
Regulation Number874.1820
Classification Product Code
ETN  
Date Received10/02/1992
Decision Date 11/24/1992
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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