Cleared Traditional

WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP

K843188 · Wells Johnson Co. · General Hospital
Sep 1984
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K843188 is an FDA 510(k) clearance for the WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Wells Johnson Co. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1984, 38 days after receiving the submission on August 13, 1984. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K843188 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 1984
Decision Date September 20, 1984
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code JOL — Catheter And Tip, Suction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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