Cleared Traditional

MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE

K132880 · Medical Components, Inc. · General Hospital
Jan 2014
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K132880 is an FDA 510(k) clearance for the MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on January 8, 2014, 117 days after receiving the submission on September 13, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K132880 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2013
Decision Date January 08, 2014
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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