MPC-1000 Injection Cap/Plug

FDA 510(k) K925927 · Molded Products, Inc.

Substantially Equivalent

510(k) numberK925927

Submission

Device name
MPC-1000 Injection Cap/Plug
Applicant
Molded Products, Inc.
Harlan, IA, US
Received
November 23, 1992
Decision date
August 16, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FPA – Set, Administration, Intravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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More from B.Braun Medical, Inc.

510(k)DeviceDecision
K022068Tubing, Dialysate (and Connector)FID · Traditional 09/23/2002SE
K010366Disposable Storage CapFJI · Abbreviated 11/28/2001SE
K010712Dialysate Line with Connectors/Re-Use Wash-Out LinesFID · Abbreviated 09/27/2001SE
K003712Modification to Male to Male Luer AdapterKOC · Traditional 05/16/2001SE
K925978MPC-80 TransducerFIB · Traditional 01/14/1994SE
K925930MPC-150 Male to Male Luer AdapterFPA · Traditional 08/16/1993SE

Questions and answers

When was MPC-1000 Injection Cap/Plug cleared by the FDA?

MPC-1000 Injection Cap/Plug (K925927) received a 510(k) decision of Substantially Equivalent on August 16, 1993, 266 days after the submission was received.

What is the product code of K925927?

The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.