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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 K881308
Device Name BREATH-EASY
Applicant
Icor AB
Ulvsundavagen 178 B
Bromma,  SE 161 30
Applicant Contact CARL HAMILTON
Correspondent
Icor AB
Ulvsundavagen 178 B
Bromma,  SE 161 30
Correspondent Contact CARL HAMILTON
Regulation Number868.5375
Classification Product Code
BYD  
Date Received03/28/1988
Decision Date 05/17/1988
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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