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FDA 510(k)

DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING

K-Number: K991061 · 1999-06-28

ApplicantDermaphylyx, Inc.
Decision Date1999-06-28
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Dermaphylyx, Inc.. It received FDA 510(k) clearance on 1999-06-28 under 510(k) number K991061. 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 DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING?

DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1999-06-28. The listed applicant is Dermaphylyx, Inc.. The 510(k) number is K991061.

When did DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING receive FDA 510(k) clearance?

DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING received FDA 510(k) clearance on 1999-06-28, under 510(k) number K991061.

Who is the listed applicant for DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING?

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

What is the FDA product code for DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING?

The FDA product code for DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING is NAE.

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Other records listing Dermaphylyx, 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.

K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSK991920DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSINGK991933DERMAPHYLYX FOAM ISLAND DRESSINGK991609DERMAPHYLYX SUPER ABSORBENT FIBER DRESSINGK991608DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGK990875DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING

View all 9 devices →

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.K972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZESLudlow Technical ProductsK971597COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)Coloplast Corp.

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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