Cleared Traditional

K961775 - PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
(FDA 510(k) Clearance)

K961775 · Smith & Nephew United, Inc. · General & Plastic Surgery

Jul 1996

Decision

69d

Days

—

Risk

K961775 is an FDA 510(k) clearance for the PROFORE FOUR-LAYER BANDAGE SYSTEM KIT. This device is classified as a Gauze/sponge, Internal.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on July 16, 1996, 69 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	K961775 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 1996
Decision Date	July 16, 1996
Days to Decision	69 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement