Cleared Traditional

MPC-1000 INJECTION CAP/PLUG

K925927 · Molded Products, Inc. · General Hospital
Aug 1993
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K925927 is an FDA 510(k) clearance for the MPC-1000 INJECTION CAP/PLUG, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Molded Products, Inc. (Harlan, US). The FDA issued a Cleared decision on August 16, 1993, 266 days after receiving the submission on November 23, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K925927 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 1992
Decision Date August 16, 1993
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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