EPI-FOAM SILICONE SHEETING— 510(k) K991604

Substantially Equivalent

Biodermis Corp.

FDA 510(k) clearance K991604 for EPI-FOAM SILICONE SHEETING, Substantially Equivalent on 1999-06-09. Applicant: Biodermis Corp.. Device class: 1.

Clearance details

Applicant: Biodermis Corp.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1999-05-10
Decision date: 1999-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, 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.