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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, electrical, evoked response
510(k) Number K822744
Device Name #ST10 PROGR. EVOKED RESPONSE STIMULATOR
Applicant
TECA, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TECA, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number882.1870
Classification Product Code
GWF  
Date Received09/10/1982
Decision Date 11/03/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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