PDM SILOXANE PROSTHETIC NOSE— 510(k) K832153

Name: FDA 510(k) clearance K832153
Creator: U.S. Food and Drug Administration
Published: 1983-12-09

Substantially Equivalent

Delaware Prosthetics, Inc.

FDA 510(k) clearance K832153 for PDM SILOXANE PROSTHETIC NOSE, Substantially Equivalent on 1983-12-09. Applicant: Delaware Prosthetics, Inc.. Device class: 1.

Clearance details

Applicant: Delaware Prosthetics, Inc.
Product code: Code GBI
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1983-07-05
Decision date: 1983-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K832151 — PDM SILOXANE PROSTHETIC ORBIT1983-12-19
K832152 — PDM SILOXANE PROSTHETIC EAR1983-12-09
K832148 — PDM SILOXANE PROSTHETIC CHIN IMPLANT1983-11-28
K832149 — PDM SILOXANE PROSTHETIC OBTURATOR1983-11-28

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