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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 K831715
Device Name NEUROTRAC
Applicant
HDC CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HDC CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.1820
Classification Product Code
ETN  
Date Received05/27/1983
Decision Date 07/07/1983
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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