510(k) K932649

PHARMAFEED by Plasco, Inc. — Product Code KPE

K932649 is an FDA 510(k) premarket notification submitted by Plasco, Inc. for the device "PHARMAFEED". The FDA issued a decision of Substantially Equivalent on November 16, 1993. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Plasco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1993
Date Received
June 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type