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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 K012526
Device Name BIOTEQUE SCALP VEIN SET
Applicant
BIOTEQUE CORP.
900 N. SWITZER CANYON DR. #142
FLAGSTAFF,  AZ  86001
Applicant Contact ALLEN REICH
Correspondent
BIOTEQUE CORP.
900 N. SWITZER CANYON DR. #142
FLAGSTAFF,  AZ  86001
Correspondent Contact ALLEN REICH
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/06/2001
Decision Date 09/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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