Cleared Traditional

Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01

K041564 · Bioject Medical Technologies, Inc. · General Hospital
Jul 2004
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K041564 is an FDA 510(k) clearance for the Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Bioject Medical Technologies, Inc. (Bedminster, US). The FDA issued a Cleared decision on July 16, 2004, 36 days after receiving the submission on June 10, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K041564 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2004
Decision Date July 16, 2004
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LHI — Set, I.v. Fluid Transfer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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