510(k) K896544

MD2 PERSONAL INFUSION SYSTEM by Norfolk Medical Products, Inc. — Product Code FRN

K896544 is an FDA 510(k) premarket notification submitted by Norfolk Medical Products, Inc. for the device "MD2 PERSONAL INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 2, 1990. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Norfolk Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 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