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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condenser, Heat And Moisture (Artificial Nose)
510(k) Number K915786
Device Name BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.
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 Number868.5375
Classification Product Code
BYD  
Date Received12/24/1991
Decision Date 06/30/1992
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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