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FDA 510(k)

EPI-FOAM SILICONE SHEETING

K-Number: K991604 · 1999-06-09

ApplicantBiodermis Corp.
Decision Date1999-06-09
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPI-FOAM SILICONE 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 1999-06-09 under 510(k) number K991604. 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-FOAM SILICONE SHEETING?

EPI-FOAM SILICONE SHEETING is a medical device that received FDA 510(k) clearance on 1999-06-09. The listed applicant is Biodermis Corp.. The 510(k) number is K991604.

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

EPI-FOAM SILICONE SHEETING received FDA 510(k) clearance on 1999-06-09, under 510(k) number K991604.

Who is the listed applicant for EPI-FOAM SILICONE 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-FOAM SILICONE SHEETING?

The FDA product code for EPI-FOAM SILICONE 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.

K003948EPI-DERM SILICONE GEL SHEETINGK992146SCARAID SILICONE GEL 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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