Cleared Traditional

K844674 - APPLIED GAUZE SPONGE 2X2X8 PLY (FDA 510(k) Clearance)

Apr 1985
Decision
122d
Days
-
Risk

K844674 is an FDA 510(k) clearance for the APPLIED GAUZE SPONGE 2X2X8 PLY. This device is classified as a Gauze/sponge, Internal.

Submitted by Applied Medical (Fort Worth, US). The FDA issued a Cleared decision on April 1, 1985, 122 days after receiving the submission on November 30, 1984.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K844674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1984
Decision Date April 01, 1985
Days to Decision 122 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -

Device Classification

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