Cleared Traditional

CONTAIN(TM)

K874505 · Arbor Technologies, Inc. · General Hospital
May 1988
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K874505 is an FDA 510(k) clearance for the CONTAIN(TM), a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Arbor Technologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on May 20, 1988, 200 days after receiving the submission on November 2, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K874505 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1987
Decision Date May 20, 1988
Days to Decision 200 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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