Cleared Traditional

ASPIRATING TUBING

K832519 · Wells Johnson Co. · General Hospital
Oct 1983
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K832519 is an FDA 510(k) clearance for the ASPIRATING TUBING, a Tubing, Noninvasive (Class II — Special Controls, product code GAZ), submitted by Wells Johnson Co. (Walker, US). The FDA issued a Cleared decision on October 20, 1983, 73 days after receiving the submission on August 8, 1983. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K832519 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 1983
Decision Date October 20, 1983
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code GAZ — Tubing, Noninvasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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