Cleared Traditional

CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS

K931748 · Tri-State Hospital Supply Corp. · General Hospital
Feb 1994
Decision
323d
Days
Class 2
Risk

About This 510(k) Submission

K931748 is an FDA 510(k) clearance for the CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Tri-State Hospital Supply Corp. (Howell, US). The FDA issued a Cleared decision on February 25, 1994, 323 days after receiving the submission on April 8, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K931748 FDA.gov
FDA Decision Cleared SESK
Date Received April 08, 1993
Decision Date February 25, 1994
Days to Decision 323 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5965

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