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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K002449
Device Name BIOTEQ I.V. (INTRAVENOUS) SET
Applicant
Bioteque Corp.
900 N. Switzer Canyon Dr. #142
Flaggstaff,  AZ  86001
Applicant Contact JENNIFER CHEN
Correspondent
Bioteque Corp.
900 N. Switzer Canyon Dr. #142
Flaggstaff,  AZ  86001
Correspondent Contact JENNIFER CHEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/09/2000
Decision Date 12/22/2000
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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