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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 K941987
Device Name HEAT AND MOISTURE EXCHANGERS AND FILTERS
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 Received04/25/1994
Decision Date 08/15/1994
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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