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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube tracheostomy and tube cuff
510(k) Number K897005
Device Name BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE
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 Number868.5800
Classification Product Code
JOH  
Date Received12/18/1989
Decision Date 03/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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