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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 K880594
Device Name VACUGUARD(TM)
Applicant
Habley Medical Technology Corp.
22982 Alcalde Dr.
Laguana Hills,  CA  92653
Applicant Contact HABER, PHD
Correspondent
Habley Medical Technology Corp.
22982 Alcalde Dr.
Laguana Hills,  CA  92653
Correspondent Contact HABER, PHD
Regulation Number862.1675
Classification Product Code
JKA  
Date Received02/11/1988
Decision Date 04/28/1988
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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