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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
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