Cleared Traditional

EAR AND EYE SPONGES

K873831 · Ormed Mfg., Inc. · General & Plastic Surgery
Oct 1987
Decision
14d
Days
—
Risk

About This 510(k) Submission

K873831 is an FDA 510(k) clearance for the EAR AND EYE SPONGES, a Gauze/sponge, Internal, submitted by Ormed Mfg., Inc. (Buffalo, US). The FDA issued a Cleared decision on October 5, 1987, 14 days after receiving the submission on September 21, 1987. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K873831 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1987
Decision Date October 05, 1987
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code EFQ — Gauze/sponge, Internal
Device Class —

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