Cleared Traditional

K925588 - NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
(FDA 510(k) Clearance)

K925588 · North American Sterilization & Packaging Co. · General & Plastic Surgery device

Dec 1993

Decision

393d

Days

—

Risk

K925588 is an FDA 510(k) clearance for the NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI..

Submitted by North American Sterilization & Packaging Co. (Sparta, US). The FDA issued a Cleared decision on December 3, 1993, 393 days after receiving the submission on November 5, 1992.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K925588 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 05, 1992
Decision Date	December 03, 1993
Days to Decision	393 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement