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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 K900150
Device Name HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE
Applicant
ICOR AB
ULVSUNDAVAGEN 178 B
BROMMA,  SE 161 30
Applicant Contact GEDEON, PHD
Correspondent
ICOR AB
ULVSUNDAVAGEN 178 B
BROMMA,  SE 161 30
Correspondent Contact GEDEON, PHD
Regulation Number868.5375
Classification Product Code
BYD  
Date Received01/11/1990
Decision Date 01/25/1990
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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