Cleared Traditional

GAUZE SPONGE

K882527 · Ormed Mfg., Inc. · General & Plastic Surgery
Jul 1988
Decision
27d
Days
—
Risk

About This 510(k) Submission

K882527 is an FDA 510(k) clearance for the GAUZE SPONGE, a Gauze/sponge, Internal, submitted by Ormed Mfg., Inc. (Buffalo, US). The FDA issued a Cleared decision on July 18, 1988, 27 days after receiving the submission on June 21, 1988. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K882527 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 1988
Decision Date July 18, 1988
Days to Decision 27 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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