510(k) K973497

HUBERLOC by Medcare Medical Group, Inc. — Product Code LJT

K973497 is an FDA 510(k) premarket notification submitted by Medcare Medical Group, Inc. for the device "HUBERLOC". The FDA issued a decision of Substantially Equivalent on January 13, 1998. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Medcare Medical Group, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1998
Date Received
September 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type