Cleared Traditional

PLASTIC TUBING CONNECTORS

K831920 · Polymer Technology Corp. · General Hospital
Jul 1983
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K831920 is an FDA 510(k) clearance for the PLASTIC TUBING CONNECTORS, a Tube, Aspirating, Flexible, Connecting (Class II — Special Controls, product code BYY), submitted by Polymer Technology Corp. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983, 35 days after receiving the submission on June 14, 1983. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K831920 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1983
Decision Date July 19, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code BYY — Tube, Aspirating, Flexible, Connecting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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