Cleared Traditional

K844726 - GAUZE SPONGE 4X4X12 PLY (FDA 510(k) Clearance)

K844726 · Applied Medical · General & Plastic Surgery device

Apr 1985

Decision

118d

Days

Risk

K844726 is an FDA 510(k) clearance for the GAUZE SPONGE 4X4X12 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, 118 days after receiving the submission on December 4, 1984.

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

Submission Details

510(k) Number	K844726 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 04, 1984
Decision Date	April 01, 1985
Days to Decision	118 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	-

Device Classification

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