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FDA 510(k)

DERMAMEND FOAM ISLAND DRESSING

K-Number: K970600 · 1997-05-08

ApplicantDermarx Corp.
Decision Date1997-05-08
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERMAMEND FOAM ISLAND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Dermarx Corp.. It received FDA 510(k) clearance on 1997-05-08 under 510(k) number K970600. 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 DERMAMEND FOAM ISLAND DRESSING?

DERMAMEND FOAM ISLAND DRESSING is a medical device that received FDA 510(k) clearance on 1997-05-08. The listed applicant is Dermarx Corp.. The 510(k) number is K970600.

When did DERMAMEND FOAM ISLAND DRESSING receive FDA 510(k) clearance?

DERMAMEND FOAM ISLAND DRESSING received FDA 510(k) clearance on 1997-05-08, under 510(k) number K970600.

Who is the listed applicant for DERMAMEND FOAM ISLAND DRESSING?

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

What is the FDA product code for DERMAMEND FOAM ISLAND DRESSING?

The FDA product code for DERMAMEND FOAM ISLAND DRESSING is KMF.

Related Clinical Trials

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.

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Other records listing Dermarx 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.

K972336DERMAMEND HYDROGEL GAUZE DRESSINGK962089DERMAMEND GELK951561DYNASORB

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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