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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 K885131
Device Name KIT PAK SUCTION CATHETER KIT
Applicant
Kit Pak, Inc.
825 Chase Ave.
Elk Grove Village,  IL  60007
Applicant Contact JAMES S SANDERS
Correspondent
Kit Pak, Inc.
825 Chase Ave.
Elk Grove Village,  IL  60007
Correspondent Contact JAMES S SANDERS
Regulation Number868.6810
Classification Product Code
BSY  
Date Received12/12/1988
Decision Date 01/09/1989
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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