Cleared Traditional

NORFOLK NORPORT (TM) -SP (SKIN PARALLEL)

K872838 · Norfolk Medical Products, Inc. · General Hospital
Aug 1987
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K872838 is an FDA 510(k) clearance for the NORFOLK NORPORT (TM) -SP (SKIN PARALLEL), 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 August 25, 1987, 36 days after receiving the submission on July 20, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K872838 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1987
Decision Date August 25, 1987
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

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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