510(k) K071735

MODIFICATION TO DISPOSABLE INFUSION PUMP KIT by Symbios Medical Products, LLC — Product Code MEB

K071735 is an FDA 510(k) premarket notification submitted by Symbios Medical Products, LLC for the device "MODIFICATION TO DISPOSABLE INFUSION PUMP KIT". The FDA issued a decision of Substantially Equivalent on July 19, 2007. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Symbios Medical Products, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2007
Date Received
June 26, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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