Cleared Traditional

DISPOSINEEDLE SHARPS DISPOSAL UNIT

K897095 · Specialites Septodont · General Hospital
Jan 1990
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K897095 is an FDA 510(k) clearance for the DISPOSINEEDLE SHARPS DISPOSAL UNIT, a Container, Sharps (Class II — Special Controls, product code MMK), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on January 17, 1990, 27 days after receiving the submission on December 21, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K897095 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1989
Decision Date January 17, 1990
Days to Decision 27 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

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