SILIMED MALAR IMPLANT— 510(k) K981835

Substantially Equivalent

Silimed, LLC

FDA 510(k) clearance K981835 for SILIMED MALAR IMPLANT, Substantially Equivalent on 1998-07-09. Applicant: Silimed, LLC. Device class: 2.

Clearance details

Applicant: Silimed, LLC
Product code: Code LZK
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 1998-05-26
Decision date: 1998-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZK

K021419 — AART MALAR IMPLANT2002-07-02
K002886 — IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)2000-11-24
K992240 — PILLAR MALAR IMPLANT1999-11-22
K983756 — SURGIFORM ANATOMICAL MALAR1998-11-20
K982763 — SEARE BIOMEDICAL MALAR IMPLANTS1998-09-30

More clearances from Silimed, LLC

K974479 — SILIMED VAGINAL STENT1998-08-05
K981852 — SILIMED TISSUE EXPANDER1998-08-05
K981850 — SILIMED CHIN IMPLANTS1998-07-09
K981851 — SILIMED SILICONE CARVING BLOCK1998-07-09
K981833 — SILIMED NASAL L SHAPED IMPLANT1998-06-26

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