Cleared Traditional

K853759 - CUSTOM PROCEDURAL TRAY PROCEDURAL KIT
(FDA 510(k) Clearance)

K853759 · Charles Atkins & Co. · General & Plastic Surgery device
Nov 1985
Decision
69d
Days
—
Risk

K853759 is an FDA 510(k) clearance for the CUSTOM PROCEDURAL TRAY PROCEDURAL KIT..

Submitted by Charles Atkins & Co. (Atlanta, US). The FDA issued a Cleared decision on November 17, 1985, 69 days after receiving the submission on September 9, 1985.

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

Submission Details

510(k) Number K853759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received September 09, 1985
Decision Date November 17, 1985
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code —
Device Class —