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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 K962078
Device Name TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER
Applicant
Continental Medical Laboratories, Inc.
817 W. Mohr Ave.
P.O. Box 306
Waterford,  WI  53185
Applicant Contact JOSEPH DUNN
Correspondent
Continental Medical Laboratories, Inc.
817 W. Mohr Ave.
P.O. Box 306
Waterford,  WI  53185
Correspondent Contact JOSEPH DUNN
Regulation Number868.5800
Classification Product Code
JOH  
Date Received05/28/1996
Decision Date 10/11/1996
Decision Substantially Equivalent - Kit (SESK)
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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