KMC NEWSKIN— 510(k) K974143

Substantially Equivalent

Kmc Intl. Co.

FDA 510(k) clearance K974143 for KMC NEWSKIN, Substantially Equivalent on 1998-03-27. Applicant: Kmc Intl. Co.. Device class: 1.

Clearance details

Applicant: Kmc Intl. Co.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1997-11-03
Decision date: 1998-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pasadena, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MDA

K112131 — NEODYNE DRESSING2011-09-29
K111733 — CORELEADER SCAR-DIMMER2011-09-22
K083718 — BEAU RX SCAR CARE GEL2009-01-26
K053481 — KELO-COTE SPRAY2006-04-14
K041704 — NEWGEL AND NEWGEL PLUS E2005-10-17

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