Cleared Traditional

MEDI-VAC FLEXI-CLEAR SUCTION HANDLE

K964127 · Allegiance Healthcare Corp. · General Hospital
Dec 1996
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K964127 is an FDA 510(k) clearance for the MEDI-VAC FLEXI-CLEAR SUCTION HANDLE, a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on December 31, 1996, 77 days after receiving the submission on October 15, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K964127 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1996
Decision Date December 31, 1996
Days to Decision 77 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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