Cleared Traditional

CROSSTEX NON-WOVEN SPONGES

K984187 · Crosstex Intl. · General & Plastic Surgery
Feb 1999
Decision
87d
Days
Risk

About This 510(k) Submission

K984187 is an FDA 510(k) clearance for the CROSSTEX NON-WOVEN SPONGES, a Gauze/sponge, Internal, submitted by Crosstex Intl. (Great Neck,, US). The FDA issued a Cleared decision on February 18, 1999, 87 days after receiving the submission on November 23, 1998. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K984187 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 1998
Decision Date February 18, 1999
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code EFQ — Gauze/sponge, Internal
Device Class

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