Cleared Traditional

SUCTION CANISTER

K771737 · Bemis Health Care · General Hospital
Dec 1977
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K771737 is an FDA 510(k) clearance for the SUCTION CANISTER, a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Bemis Health Care (Mchenry, US). The FDA issued a Cleared decision on December 20, 1977, 96 days after receiving the submission on September 15, 1977. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K771737 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1977
Decision Date December 20, 1977
Days to Decision 96 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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