510(k) K850035

EMPTY SOLUTION TRANSFER CONTAINER by The Healthcare Group Laboratories, Inc. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1985
Date Received
January 7, 1985
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