510(k) K932641

EMPTY MIXING CONTAINER by Douglas Medical Products Corp. — Product Code KPE

K932641 is an FDA 510(k) premarket notification submitted by Douglas Medical Products Corp. for the device "EMPTY MIXING CONTAINER". The FDA issued a decision of Substantially Equivalent on November 10, 1993. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Douglas Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 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