SEARE BIOMEDICAL MALAR IMPLANTS— 510(k) K982763

Name: FDA 510(k) clearance K982763
Creator: U.S. Food and Drug Administration
Published: 1998-09-30

Substantially Equivalent

Seare Biomedical Corp.

FDA 510(k) clearance K982763 for SEARE BIOMEDICAL MALAR IMPLANTS, Substantially Equivalent on 1998-09-30. Applicant: Seare Biomedical Corp.. Device class: 2.

Clearance details

Applicant: Seare Biomedical Corp.
Product code: Code LZK
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 1998-08-06
Decision date: 1998-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZK

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K992240 — PILLAR MALAR IMPLANT1999-11-22
K983756 — SURGIFORM ANATOMICAL MALAR1998-11-20
K981835 — SILIMED MALAR IMPLANT1998-07-09

More clearances from Seare Biomedical Corp.

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K983630 — SEARE BIOMEDICAL SILICONE RODS1998-12-11
K983792 — SEARE BIOMEDICAL SILICONE TISSUE EXPANDER1998-12-11
K982752 — SEARE BIOMEDICAL CHIN IMPLANTS1998-09-30
K982753 — SEARE BIOMEDICAL NASAL IMPLANTS1998-09-30
K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT1998-09-30

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