Cleared Traditional

K854809 - WHITE CROSS STERILE PAD 4IN. X 4IN.
(FDA 510(k) Clearance)

Jan 1986
Decision
41d
Days
Risk

K854809 is an FDA 510(k) clearance for the WHITE CROSS STERILE PAD 4IN. X 4IN...

Submitted by American White Cross, Inc. (New Rochelle, US). The FDA issued a Cleared decision on January 13, 1986, 41 days after receiving the submission on December 3, 1985.

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

Submission Details

510(k) Number K854809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1985
Decision Date January 13, 1986
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class