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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K940041
Device Name COLIBRI
Applicant
ICOR AB
ULVSUNDAVAGEN 178 B
BROMMA,  SE 161 30
Applicant Contact ANDRAS GEDEON D.SC.
Correspondent
ICOR AB
ULVSUNDAVAGEN 178 B
BROMMA,  SE 161 30
Correspondent Contact ANDRAS GEDEON D.SC.
Regulation Number868.5730
Classification Product Code
BTR  
Date Received01/04/1994
Decision Date 07/27/1994
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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