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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K900856
Device Name VEN-O-VAC BLOOD COLLECTION VACUUM TUBES
Applicant
Artefactos DE Vidrio S.A. DE C.V.
Canela # 346
Col. Granjas
Mexico,  MX
Applicant Contact CAMPS PEREZ
Correspondent
Artefactos DE Vidrio S.A. DE C.V.
Canela # 346
Col. Granjas
Mexico,  MX
Correspondent Contact CAMPS PEREZ
Regulation Number862.1675
Classification Product Code
JKA  
Date Received02/23/1990
Decision Date 09/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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