Cleared Traditional

DELIVERY TUBE SET #2226

K822761 · Delta Medical Industries · General Hospital
Sep 1982
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K822761 is an FDA 510(k) clearance for the DELIVERY TUBE SET #2226, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Delta Medical Industries (Mchenry, US). The FDA issued a Cleared decision on September 30, 1982, 16 days after receiving the submission on September 14, 1982. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K822761 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1982
Decision Date September 30, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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