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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 K904729
Device Name BLOM-SINGER SHOWER GUARD
Applicant
Helix Medical, Inc.
210 Santa Barbera St.
Santa Barbera,  CA  93101
Applicant Contact ANN KORSAN
Correspondent
Helix Medical, Inc.
210 Santa Barbera St.
Santa Barbera,  CA  93101
Correspondent Contact ANN KORSAN
Regulation Number874.3730
Classification Product Code
EWL  
Date Received10/17/1990
Decision Date 02/28/1991
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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