Cleared Traditional

NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED

K942784 · Norfolk Medical Products, Inc. · General Hospital
May 1995
Decision
322d
Days
Class 2
Risk

About This 510(k) Submission

K942784 is an FDA 510(k) clearance for the NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Norfolk Medical Products, Inc. (Skokie, US). The FDA issued a Cleared decision on May 2, 1995, 322 days after receiving the submission on June 14, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K942784 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1994
Decision Date May 02, 1995
Days to Decision 322 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

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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