510(k) K896546

HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE) by Block Medical, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1990
Date Received
November 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type