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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 K945287
Device Name INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE
Applicant
Helix Medical, Inc.
1110 Mark Ave.
Carpinteria,  CA  93013
Applicant Contact STEPHEN W LAGUETTE
Correspondent
Helix Medical, Inc.
1110 Mark Ave.
Carpinteria,  CA  93013
Correspondent Contact STEPHEN W LAGUETTE
Regulation Number874.3730
Classification Product Code
EWL  
Date Received10/31/1994
Decision Date 12/09/1994
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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