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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 K952823
Device Name FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE
Applicant
Icor Ab
Ulvsundavagen 178 B
Bromma,  SE 161 30
Applicant Contact ANDRAS GEDEON
Correspondent
Icor Ab
Ulvsundavagen 178 B
Bromma,  SE 161 30
Correspondent Contact ANDRAS GEDEON
Regulation Number868.5375
Classification Product Code
BYD  
Date Received06/20/1995
Decision Date 07/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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