Cleared Traditional

SAFE-T-CAP NEEDLE COVER

K896219 · Ausmedics Pty , Ltd. · Dental

Jan 1990

Decision

87d

Days

Class 1

Risk

About This 510(k) Submission

K896219 is an FDA 510(k) clearance for the SAFE-T-CAP NEEDLE COVER, a Needle, Dental (Class I — General Controls, product code DZM), submitted by Ausmedics Pty , Ltd. (Washington D.C., US). The FDA issued a Cleared decision on January 22, 1990, 87 days after receiving the submission on October 27, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.4730.

Submission Details

510(k) Number	K896219 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 1989
Decision Date	January 22, 1990
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—