Cleared Traditional

1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT

K895202 · Transidyne General Corp. · General & Plastic Surgery

Sep 1989

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K895202 is an FDA 510(k) clearance for the 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT, a General Surgery Tray (Class II — Special Controls, product code LRO), submitted by Transidyne General Corp. (Ann Arbor, US). The FDA issued a Cleared decision on September 15, 1989, 28 days after receiving the submission on August 18, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K895202 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 1989
Decision Date	September 15, 1989
Days to Decision	28 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

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