NON-STERILE SUTURE NEEDLES— 510(k) K881394

Name: FDA 510(k) clearance K881394
Creator: U.S. Food and Drug Administration
Published: 1988-04-08

Substantially Equivalent

China National Medicines C/O Havel'S

FDA 510(k) clearance K881394 for NON-STERILE SUTURE NEEDLES, Substantially Equivalent on 1988-04-08. Applicant: China National Medicines C/O Havel'S. Device class: 1.

Clearance details

Applicant: China National Medicines C/O Havel'S
Product code: Code GDL
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1988-04-04
Decision date: 1988-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDL

view all

K851781 — 25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES1985-06-20
K851782 — 25-450 TO 25-540 VARIOUS SUTURE FORCEPS1985-06-20
K813589 — SHARTPOINT EYED NEEDLES1982-01-18
K812566 — UNIVERSAL SUTURE PASSER1981-11-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.