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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 K854118
Device Name DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS
Applicant
Dacomed Corp.
1701 E. 79th St., Suite 17
Minneapolis,  MN  55425
Applicant Contact MICHAEL W WALSH
Correspondent
Dacomed Corp.
1701 E. 79th St., Suite 17
Minneapolis,  MN  55425
Correspondent Contact MICHAEL W WALSH
Regulation Number874.3730
Classification Product Code
EWL  
Date Received10/09/1985
Decision Date 03/17/1986
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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