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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 K902112
Device Name BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT
Applicant
HELIX MEDICAL, INC.
210 SANTA BARBERA ST.
SANTA BARBERA,  CA  93101
Applicant Contact CHRISTINE EMANUEL
Correspondent
HELIX MEDICAL, INC.
210 SANTA BARBERA ST.
SANTA BARBERA,  CA  93101
Correspondent Contact CHRISTINE EMANUEL
Regulation Number874.3730
Classification Product Code
EWL  
Date Received05/09/1990
Decision Date 08/01/1990
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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