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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, battery-powered
510(k) Number K896368
Device Name MODIFIED AXOSTIM
Applicant
SINGER MEDICAL PRODUCTS, INC.
790 MAPLE LN.
BENSENVILLE,  IL  60106
Applicant Contact JAMES I BECK
Correspondent
SINGER MEDICAL PRODUCTS, INC.
790 MAPLE LN.
BENSENVILLE,  IL  60106
Correspondent Contact JAMES I BECK
Regulation Number868.2775
Classification Product Code
BXN  
Date Received11/06/1989
Decision Date 11/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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