Cleared Traditional

NEEDLE SAFETY COVER

K950098 · Hammer-Plane, Inc. · Anesthesiology

Aug 1995

Decision

213d

Days

Class 1

Risk

About This 510(k) Submission

K950098 is an FDA 510(k) clearance for the NEEDLE SAFETY COVER, a Arterial Blood Sampling Kit (Class I — General Controls, product code CBT), submitted by Hammer-Plane, Inc. (Simi Valley, US). The FDA issued a Cleared decision on August 11, 1995, 213 days after receiving the submission on January 10, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1100.

Submission Details

510(k) Number	K950098 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 1995
Decision Date	August 11, 1995
Days to Decision	213 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement

Device Classification

Product Code	CBT — Arterial Blood Sampling Kit
Device Class	Class I — General Controls
CFR Regulation	21 CFR 868.1100
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.