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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 K991587
Device Name BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
Applicant
HELIX MEDICAL, INC.
1110 MARK AVE.
CARPINTERIA,  CA  93013
Applicant Contact CYNTHIA ANDERSON
Correspondent
HELIX MEDICAL, INC.
1110 MARK AVE.
CARPINTERIA,  CA  93013
Correspondent Contact CYNTHIA ANDERSON
Regulation Number874.3730
Classification Product Code
EWL  
Date Received05/07/1999
Decision Date 06/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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