Cleared Traditional

K874342 - LIGATURE CARRIER/PACKER, HYDROXYLAPATITE
(FDA 510(k) Clearance)

K874342 · Cox-Uphuff Intl. · General & Plastic Surgery
Nov 1987
Decision
24d
Days
Class 1
Risk

K874342 is an FDA 510(k) clearance for the LIGATURE CARRIER/PACKER, HYDROXYLAPATITE, a Carrier, Ligature (Class I — General Controls, product code GEJ), submitted by Cox-Uphuff Intl. (Santa Barbara, US). The FDA issued a Cleared decision on November 13, 1987, 24 days after receiving the submission on October 20, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K874342 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1987
Decision Date November 13, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GEJ — Carrier, Ligature
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800