SEARE BIOMEDICAL SILICONE BLOCK— 510(k) K983043

Name: FDA 510(k) clearance K983043
Creator: U.S. Food and Drug Administration
Published: 1998-09-30

Substantially Equivalent

Seare Biomedical Corp.

FDA 510(k) clearance K983043 for SEARE BIOMEDICAL SILICONE BLOCK, 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: 1998-08-31
Decision date: 1998-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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K021337 — AART PECTORALIS IMPLANT2002-07-03
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K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT1998-09-30
K973729 — POWERFLEX PEC IMPLANT1997-12-24
K961072 — PEC IMPLANT1996-04-19

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
K982763 — SEARE BIOMEDICAL MALAR IMPLANTS1998-09-30

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