Cleared Traditional

K980490 - SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
(FDA 510(k) Clearance)

K980490 · Sage Products, Inc. · General Hospital

Feb 1998

Decision

15d

Days

Class 2

Risk

K980490 is an FDA 510(k) clearance for the SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS, a Container, Sharps (Class II — Special Controls, product code MMK), submitted by Sage Products, Inc. (Crystal Lake, US). The FDA issued a Cleared decision on February 24, 1998, 15 days after receiving the submission on February 9, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K980490 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 1998
Decision Date	February 24, 1998
Days to Decision	15 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF