Cleared Traditional

K872947 - POREX QUALITY PLASTIC SURGERY INSTRUMENTS
(FDA 510(k) Clearance)

K872947 · Porex Medical · General & Plastic Surgery
Aug 1987
Decision
24d
Days
Class 1
Risk

K872947 is an FDA 510(k) clearance for the POREX QUALITY PLASTIC SURGERY INSTRUMENTS, a Chisel (osteotome) (Class I — General Controls, product code KDG), submitted by Porex Medical (Fairburn, US). The FDA issued a Cleared decision on August 21, 1987, 24 days after receiving the submission on July 28, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K872947 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1987
Decision Date August 21, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KDG — Chisel (osteotome)
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820