Cleared Traditional

EXTERNAL MECHANICAL FASTENER

K854068 · Wells Johnson Co. · General & Plastic Surgery

Nov 1985

Decision

49d

Days

—

Risk

About This 510(k) Submission

K854068 is an FDA 510(k) clearance for the EXTERNAL MECHANICAL FASTENER, submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on November 22, 1985, 49 days after receiving the submission on October 4, 1985. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K854068 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 04, 1985
Decision Date	November 22, 1985
Days to Decision	49 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—