VINYL SILICONE ELASTOMER MATERIAL— 510(k) K901990

Name: FDA 510(k) clearance K901990
Creator: U.S. Food and Drug Administration
Published: 1990-09-14

Substantially Equivalent

Crown Delta Corp.

FDA 510(k) clearance K901990 for VINYL SILICONE ELASTOMER MATERIAL, Substantially Equivalent on 1990-09-14. Applicant: Crown Delta Corp.. Device class: 1.

Clearance details

Applicant: Crown Delta Corp.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1990-05-02
Decision date: 1990-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorktown Heights, NY, US

Download summary PDF View on FDA.gov ↗

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