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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K896730
Device Name SUCTION CATHETER STRAIGHT/COUDE
Applicant
Unoplast A/S
Dk-3390 Hundested
Denmark,  DK
Applicant Contact ERIK ANDERSEN
Correspondent
Unoplast A/S
Dk-3390 Hundested
Denmark,  DK
Correspondent Contact ERIK ANDERSEN
Regulation Number868.6810
Classification Product Code
BSY  
Date Received11/30/1989
Decision Date 03/30/1990
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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