Cleared Traditional

K961773 - PROTEC STERILE GAUZE SPONGE
(FDA 510(k) Clearance)

K961773 · Derivadas Degasa S.A. DE C.V. · General & Plastic Surgery

Jul 1996

Decision

82d

Days

—

Risk

K961773 is an FDA 510(k) clearance for the PROTEC STERILE GAUZE SPONGE. This device is classified as a Gauze/sponge, Internal.

Submitted by Derivadas Degasa S.A. DE C.V. (Tarpon Springs, US). The FDA issued a Cleared decision on July 29, 1996, 82 days after receiving the submission on May 8, 1996.

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

Submission Details

510(k) Number	K961773 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 1996
Decision Date	July 29, 1996
Days to Decision	82 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF