Cleared Traditional

MEGA PARACENTESIS KIT

K913382 · Mega Medical, Inc. · General Hospital
Oct 1991
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K913382 is an FDA 510(k) clearance for the MEGA PARACENTESIS KIT, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Mega Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on October 8, 1991, 71 days after receiving the submission on July 29, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K913382 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1991
Decision Date October 08, 1991
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KKX — Drape, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370

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