SEARE BIOMEDICAL PECTORALIS IMPLANT— 510(k) K982762

Name: FDA 510(k) clearance K982762
Creator: U.S. Food and Drug Administration
Published: 1998-09-30

Substantially Equivalent

Seare Biomedical Corp.

FDA 510(k) clearance K982762 for SEARE BIOMEDICAL PECTORALIS IMPLANT, Substantially Equivalent on 1998-09-30. Applicant: Seare Biomedical Corp.. Device class: 2.

Clearance details

Applicant: Seare Biomedical Corp.
Product code: Code MIC
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
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 ↗

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K982753 — SEARE BIOMEDICAL NASAL IMPLANTS1998-09-30
K982763 — SEARE BIOMEDICAL MALAR IMPLANTS1998-09-30

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