510(k) K884978

PHARMA-PLAST INSULIN INFUSION SET by Pharma-Plast USA, Inc. — Product Code LZG

K884978 is an FDA 510(k) premarket notification submitted by Pharma-Plast USA, Inc. for the device "PHARMA-PLAST INSULIN INFUSION SET". The FDA issued a decision of Substantially Equivalent on June 21, 1989. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Pharma-Plast USA, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1989
Date Received
November 30, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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