510(k) K842170

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

K842170 is an FDA 510(k) premarket notification submitted by The Healthcare Group Laboratories, Inc. for the device "EMPTY SOLUTION TRANSFER CONTAINER". The FDA issued a decision of Substantially Equivalent on October 19, 1984. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. The Healthcare Group Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1984
Date Received
May 24, 1984
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