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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 K905035
Device Name AXOSTIM NERVE STIMULATOR, MODIFICATION
Applicant
Singer Medical Products, Inc.
790 Maple Ln.
Bensenville,  IL  60106
Applicant Contact DEBORAH L SINGER
Correspondent
Singer Medical Products, Inc.
790 Maple Ln.
Bensenville,  IL  60106
Correspondent Contact DEBORAH L SINGER
Regulation Number874.1820
Classification Product Code
ETN  
Date Received10/25/1990
Decision Date 04/19/1991
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
Predetermined Change
Control Plan Authorized		 No
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