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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 K896887
Device Name TRACHAEL SUCTION SET
Applicant
Orion Life Systems, Inc.
124 Messner Dr.
Wheeling,  IL  60090
Applicant Contact JOHN L LAEMMAR
Correspondent
Orion Life Systems, Inc.
124 Messner Dr.
Wheeling,  IL  60090
Correspondent Contact JOHN L LAEMMAR
Regulation Number868.6810
Classification Product Code
BSY  
Date Received12/08/1989
Decision Date 04/23/1990
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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