510(k) K931748

CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS by Tri-State Hospital Supply Corp. — Product Code LJT

K931748 is an FDA 510(k) premarket notification submitted by Tri-State Hospital Supply Corp. for the device "CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS". The FDA issued a decision of Substantially Equivalent (kit) on February 25, 1994. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Tri-State Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
February 25, 1994
Date Received
April 8, 1993
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