Cleared Traditional

WOUND FLUSH, STERILE WATER & NORMAL SALINE

K083042 · Nurse Assist, Inc. · General & Plastic Surgery
Dec 2008
Decision
65d
Days
Risk

About This 510(k) Submission

K083042 is an FDA 510(k) clearance for the WOUND FLUSH, STERILE WATER & NORMAL SALINE, a Dressing, Wound, Drug, submitted by Nurse Assist, Inc. (Carrollton, US). The FDA issued a Cleared decision on December 18, 2008, 65 days after receiving the submission on October 14, 2008. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K083042 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2008
Decision Date December 18, 2008
Days to Decision 65 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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