Cleared Special

QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE

K030721 · Ballard Medical Products · General & Plastic Surgery

Mar 2003

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K030721 is an FDA 510(k) clearance for the QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE, a General Surgery Tray (Class II — Special Controls, product code LRO), submitted by Ballard Medical Products (Draper, US). The FDA issued a Cleared decision on March 31, 2003, 24 days after receiving the submission on March 7, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K030721 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 2003
Decision Date	March 31, 2003
Days to Decision	24 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	LRO — General Surgery Tray
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4370
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance