Cleared Traditional

K803206 - SUCTION PROBE
(FDA 510(k) Clearance)

K803206 · Bemis Health Care · General Hospital
Jan 1981
Decision
35d
Days
Class 2
Risk

K803206 is an FDA 510(k) clearance for the SUCTION PROBE, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Bemis Health Care (Mchenry, US). The FDA issued a Cleared decision on January 21, 1981, 35 days after receiving the submission on December 17, 1980. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K803206 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 1980
Decision Date January 21, 1981
Days to Decision 35 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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