Cleared Traditional

CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS

K974083 · Ohmeda Medical · General Hospital
Jan 1998
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K974083 is an FDA 510(k) clearance for the CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS, a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by Ohmeda Medical (Murray Hill, US). The FDA issued a Cleared decision on January 13, 1998, 76 days after receiving the submission on October 29, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K974083 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 1997
Decision Date January 13, 1998
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMG — Stopcock, I.v. Set
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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