Cleared Traditional

TRIANGLE SPONGE

K880907 · Ormed Mfg., Inc. · General & Plastic Surgery
Mar 1988
Decision
14d
Days
—
Risk

About This 510(k) Submission

K880907 is an FDA 510(k) clearance for the TRIANGLE SPONGE, a Gauze/sponge, Internal, submitted by Ormed Mfg., Inc. (Buffalo, US). The FDA issued a Cleared decision on March 17, 1988, 14 days after receiving the submission on March 3, 1988. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K880907 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1988
Decision Date March 17, 1988
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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