Cleared Traditional

CHASE SUCKER

K971022 · Chase Medical, Inc. · General Hospital
Apr 1997
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K971022 is an FDA 510(k) clearance for the CHASE SUCKER, a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Chase Medical, Inc. (Richardson, US). The FDA issued a Cleared decision on April 17, 1997, 28 days after receiving the submission on March 20, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K971022 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1997
Decision Date April 17, 1997
Days to Decision 28 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

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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