Cleared Traditional

MEGA ARTHROGRAM KIT

K913317 · Mega Medical, Inc. · General Hospital
Oct 1991
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K913317 is an FDA 510(k) clearance for the MEGA ARTHROGRAM KIT, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Mega Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on October 31, 1991, 98 days after receiving the submission on July 25, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K913317 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1991
Decision Date October 31, 1991
Days to Decision 98 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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