SCARAID SILICONE GEL SHEETING— 510(k) K992146

Substantially Equivalent

Biodermis Corp.

FDA 510(k) clearance K992146 for SCARAID SILICONE GEL SHEETING, Substantially Equivalent on 1999-07-30. 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: 1999-06-24
Decision date: 1999-07-30
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.

K003948 — EPI-DERM SILICONE GEL SHEETING2001-01-29
K991604 — EPI-FOAM SILICONE SHEETING1999-06-09
K964047 — CRYOSIL SILICONE GEL SHEETING1997-03-19
K942156 — EPI-DERM SILICONE GEL SHEETING1994-06-13

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