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FDA 510(k)

EPI-DERM SILICONE GEL SHEETING

K-Number: K003948 · 2001-01-29

ApplicantBiodermis Corp.
Decision Date2001-01-29
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPI-DERM SILICONE GEL SHEETING is the device name listed in this FDA 510(k) record. The listed applicant is Biodermis Corp.. It received FDA 510(k) clearance on 2001-01-29 under 510(k) number K003948. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPI-DERM SILICONE GEL SHEETING?

EPI-DERM SILICONE GEL SHEETING is a medical device that received FDA 510(k) clearance on 2001-01-29. The listed applicant is Biodermis Corp.. The 510(k) number is K003948.

When did EPI-DERM SILICONE GEL SHEETING receive FDA 510(k) clearance?

EPI-DERM SILICONE GEL SHEETING received FDA 510(k) clearance on 2001-01-29, under 510(k) number K003948.

Who is the listed applicant for EPI-DERM SILICONE GEL SHEETING?

The FDA 510(k) record lists Biodermis Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPI-DERM SILICONE GEL SHEETING?

The FDA product code for EPI-DERM SILICONE GEL SHEETING is MDA.

Related Clinical Trials

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Other records listing Biodermis Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992146SCARAID SILICONE GEL SHEETINGK991604EPI-FOAM SILICONE SHEETINGK964047CRYOSIL SILICONE GEL SHEETINGK942156EPI-DERM SILICONE GEL SHEETING

Related Devices (Code: MDA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLCK053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K040307HANSON SCAR ADEHanson Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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