510(k) K990518

PEREGRINE WET SET, MODEL PD400.00 by Peregrine Surgical , Ltd. — Product Code FRN

K990518 is an FDA 510(k) premarket notification submitted by Peregrine Surgical , Ltd. for the device "PEREGRINE WET SET, MODEL PD400.00". The FDA issued a decision of Substantially Equivalent on March 25, 1999. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Peregrine Surgical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1999
Date Received
February 18, 1999
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