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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K923156
Device Name TRACHEOSTOMY CARE TRAY
Applicant
Orion Life Systems, Inc.
124 Messner Dr.
Wheeling,  IL  60090
Applicant Contact JOHN LAEMMAR
Correspondent
Orion Life Systems, Inc.
124 Messner Dr.
Wheeling,  IL  60090
Correspondent Contact JOHN LAEMMAR
Regulation Number868.5800
Classification Product Code
JOH  
Date Received06/29/1992
Decision Date 08/18/1993
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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