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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, Transcutaneous, For Pain Relief
510(k) Number K771885
Device Name IMPORTED PAIN CONTROL DEVICE
Applicant
Empi
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Empi
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/05/1977
Decision Date 11/02/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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