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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Larynx, Artificial (Battery-Powered)
510(k) Number K840892
Device Name ELECTRO-PALATE
Applicant
Cisko Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Cisko Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.3375
Classification Product Code
ESE  
Date Received02/27/1984
Decision Date 05/22/1984
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
Predetermined Change
Control Plan Authorized		 No
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