EPI-DERM SILICONE GEL SHEETING— 510(k) K942156

Substantially Equivalent

Biodermis Corp.

FDA 510(k) clearance K942156 for EPI-DERM SILICONE GEL SHEETING, Substantially Equivalent on 1994-06-13. 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: 1994-05-03
Decision date: 1994-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biodermis Corp.

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K964047 — CRYOSIL SILICONE GEL SHEETING1997-03-19

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