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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 K861949
Device Name SUCTION CATHETER KIT
Applicant
Medi-Craft , Ltd.
7526 Bath Rd.
Mississauga
Ontario L4t 1l2,  CA
Applicant Contact T. A DONAT
Correspondent
Medi-Craft , Ltd.
7526 Bath Rd.
Mississauga
Ontario L4t 1l2,  CA
Correspondent Contact T. A DONAT
Regulation Number868.6810
Classification Product Code
BSY  
Date Received05/20/1986
Decision Date 10/22/1986
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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