510(k) K874807

EXTRAVAKIT by Cancer Technologies, Inc. — Product Code FMF

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
February 4, 1988
Date Received
November 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type