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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 K895676
Device Name HEMOSTAT/STIMULATOR PROBE
Applicant
Rln Systems, Inc.
Box 6757 2019 Honeysuckle Ln.
Jefferson City,  MO  65101
Applicant Contact REA, M.D.
Correspondent
Rln Systems, Inc.
Box 6757 2019 Honeysuckle Ln.
Jefferson City,  MO  65101
Correspondent Contact REA, M.D.
Regulation Number874.1820
Classification Product Code
ETN  
Date Received09/20/1989
Decision Date 12/08/1989
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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