510(k) K860222

70 ML RESERVOIR BAG AND ADMINISTRATION SETS by Prn Services, Inc. — Product Code FRN

K860222 is an FDA 510(k) premarket notification submitted by Prn Services, Inc. for the device "70 ML RESERVOIR BAG AND ADMINISTRATION SETS". The FDA issued a decision of Substantially Equivalent on June 9, 1986. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Prn Services, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1986
Date Received
January 22, 1986
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