510(k) K830299

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

K830299 is an FDA 510(k) premarket notification submitted by The Healthcare Group Laboratories, Inc. for the device "SOLUTION TRANSFER CONTAINER". The FDA issued a decision of Substantially Equivalent on February 19, 1983. 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
February 19, 1983
Date Received
January 28, 1983
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