Cleared Traditional

OPPORTUNITY I.V. START KIT

K971093 · Opportunity, Inc. · General & Plastic Surgery
Sep 1997
Decision
176d
Days
—
Risk

About This 510(k) Submission

K971093 is an FDA 510(k) clearance for the OPPORTUNITY I.V. START KIT, a Dressing, Wound And Burn, Occlusive, submitted by Opportunity, Inc. (Highland Park, US). The FDA issued a Cleared decision on September 16, 1997, 176 days after receiving the submission on March 24, 1997. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K971093 FDA.gov
FDA Decision Cleared SN
Date Received March 24, 1997
Decision Date September 16, 1997
Days to Decision 176 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code MGP — Dressing, Wound And Burn, Occlusive
Device Class —

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