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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 K954601
Device Name NERVE LOCATOR/MONITOR SYSTEM MODIFICATION
Applicant
Rln Systems, Inc.
1021 Northeast Dr.
Jefferson City,  MO  65109
Applicant Contact J. LEE REA
Correspondent
Rln Systems, Inc.
1021 Northeast Dr.
Jefferson City,  MO  65109
Correspondent Contact J. LEE REA
Regulation Number874.1820
Classification Product Code
ETN  
Date Received09/12/1995
Decision Date 12/22/1995
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
Predetermined Change
Control Plan Authorized		 No
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