Cleared Traditional

GAUZE SPONGE, NON X-RAY DETECTABLE

K963724 · Grand Medical Products · General & Plastic Surgery
Nov 1996
Decision
74d
Days
—
Risk

About This 510(k) Submission

K963724 is an FDA 510(k) clearance for the GAUZE SPONGE, NON X-RAY DETECTABLE, a Gauze/sponge, Internal, submitted by Grand Medical Products (Schaumburg, US). The FDA issued a Cleared decision on November 29, 1996, 74 days after receiving the submission on September 16, 1996. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K963724 FDA.gov
FDA Decision Cleared SN
Date Received September 16, 1996
Decision Date November 29, 1996
Days to Decision 74 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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