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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 K082206
Device Name BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES
Applicant
HELIX MEDICAL, LLC
1110 MARK AVE.
CARPINTERIA,  CA  93013
Applicant Contact CYNTHIA ANDERSON
Correspondent
HELIX MEDICAL, LLC
1110 MARK AVE.
CARPINTERIA,  CA  93013
Correspondent Contact CYNTHIA ANDERSON
Regulation Number874.3730
Classification Product Code
EWL  
Date Received08/05/2008
Decision Date 09/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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