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FDA 510(k)

DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING

K-Number: K991608 · 1999-07-20

ApplicantDermaphylyx, Inc.
Decision Date1999-07-20
Product CodeKMF
Advisory CommitteeHO
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 1999-07-20 under 510(k) number K991608. The device is classified under product code KMF. It was reviewed by the HO 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 1999-07-20. The listed applicant is Dermaphylyx, Inc.. The 510(k) number is K991608.

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

DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING received FDA 510(k) clearance on 1999-07-20, under 510(k) number K991608.

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 KMF.

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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 DRESSINGK991061DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGK990875DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING

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Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, Inc.

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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