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FDA 510(k)

BIODERM MEDICAL HYDROGEL ISLAND DRESSING

K-Number: K951166 · 1995-06-21

ApplicantBioderm, Inc.
Decision Date1995-06-21
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIODERM MEDICAL HYDROGEL ISLAND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Bioderm, Inc.. It received FDA 510(k) clearance on 1995-06-21 under 510(k) number K951166. The device is classified under product code NAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIODERM MEDICAL HYDROGEL ISLAND DRESSING?

BIODERM MEDICAL HYDROGEL ISLAND DRESSING is a medical device that received FDA 510(k) clearance on 1995-06-21. The listed applicant is Bioderm, Inc.. The 510(k) number is K951166.

When did BIODERM MEDICAL HYDROGEL ISLAND DRESSING receive FDA 510(k) clearance?

BIODERM MEDICAL HYDROGEL ISLAND DRESSING received FDA 510(k) clearance on 1995-06-21, under 510(k) number K951166.

Who is the listed applicant for BIODERM MEDICAL HYDROGEL ISLAND DRESSING?

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

What is the FDA product code for BIODERM MEDICAL HYDROGEL ISLAND DRESSING?

The FDA product code for BIODERM MEDICAL HYDROGEL ISLAND DRESSING is NAE.

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Other records listing Bioderm, Inc. 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.

K990955MODIFICATION OF:BIODERM FOAM WOUND DRESSINGK982778BIODERM FOAM WOUND DRESSINGK982939BTF THIN FILM WOUND DRESSINGK980451BIODERM CALCIUM ALGINATE DRESSINGK973429BIODERM FOAM WOUND DRESSINGK963950BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE

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Related Devices (Code: NAE)

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.

K083721MODIFICATION TO ZENIEVARiver'S Edge Pharmaceuticals, LLCK082865MODIFICATION TO ZENIEVAGorbec Pharmaceutical Services, Inc.K073246ZENIEVAGorbec Pharmaceutical Services, Inc.K992094GILTECH PLUS HYDROGEL SKIN DRESSINGGiltech Plus, Inc.K991061DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGDermaphylyx, Inc.K972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZESLudlow Technical Products

Official Source

View on FDA Database →

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

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