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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K926097
Device Name CYBILNATE(R) UMBILICAL CATHETER
Applicant
Cyex Medical Technologies, Inc.
5080 Timberlea Blvd.
Unit 11, Mississauga, Ontario
Canada L4w 4m2,  CA
Applicant Contact KATHERINE CREWE
Correspondent
Cyex Medical Technologies, Inc.
5080 Timberlea Blvd.
Unit 11, Mississauga, Ontario
Canada L4w 4m2,  CA
Correspondent Contact KATHERINE CREWE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/03/1992
Decision Date 08/31/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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