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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 K920638
Device Name BIO-MATE PIC CATHETER
Applicant
Medevice, Inc.
5080 Timberlea Blvd.
Unit 11, Mississauga, Ontario
Canada L4w 4m2,  CA
Applicant Contact KATHERINE CREWE
Correspondent
Medevice, Inc.
5080 Timberlea Blvd.
Unit 11, Mississauga, Ontario
Canada L4w 4m2,  CA
Correspondent Contact KATHERINE CREWE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/12/1992
Decision Date 03/26/1993
Decision Substantially Equivalent - Kit (SESK)
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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