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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, laryngeal (taub)
510(k) Number K820737
Device Name PERISCOPE VOICE PROSTHESIS
Applicant
BIVONA MEDICAL TECHNOLOGIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIVONA MEDICAL TECHNOLOGIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.3730
Classification Product Code
EWL  
Date Received03/18/1982
Decision Date 04/09/1982
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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