Cleared Traditional

K896195 - NEEDLE SYRINGE DISPOSAL DEVICE (FDA 510(k) Clearance)

Nov 1989
Decision
33d
Days
Class 2
Risk

K896195 is an FDA 510(k) clearance for the NEEDLE SYRINGE DISPOSAL DEVICE. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).

Submitted by Advanced Medical Components, Inc. (Lansing, US). The FDA issued a Cleared decision on November 27, 1989, 33 days after receiving the submission on October 25, 1989.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K896195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1989
Decision Date November 27, 1989
Days to Decision 33 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code MMK — Container, Sharps
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5570