Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01

FDA 510(k) K041564 · Bioject Medical Technologies, Inc.

Substantially Equivalent

510(k) numberK041564

Submission

Device name
Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01
Applicant
Bioject Medical Technologies, Inc.
Bedminster, NJ, US
Received
June 10, 2004
Decision date
July 16, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LHI – Set, I.V. Fluid Transfer
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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More from Sfm Medical Devices GmbH

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Questions and answers

When was Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01 cleared by the FDA?

Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01 (K041564) received a 510(k) decision of Substantially Equivalent on July 16, 2004, 36 days after the submission was received.

What is the product code of K041564?

The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.