Cleared Traditional

K893135 - GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
(FDA 510(k) Clearance)

K893135 · Premium Plastics, Inc. · General Hospital
Jun 1989
Decision
58d
Days
Class 2
Risk

K893135 is an FDA 510(k) clearance for the GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Premium Plastics, Inc. (Elkhorn, US). The FDA issued a Cleared decision on June 22, 1989, 58 days after receiving the submission on April 25, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K893135 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1989
Decision Date June 22, 1989
Days to Decision 58 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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