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FDA 510(k)

ULTRAFERA WOUND DRESSING

K-Number: K964614 · 1997-02-06

ApplicantAmerican White Cross, Inc.
Decision Date1997-02-06
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ULTRAFERA WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is American White Cross, Inc.. It received FDA 510(k) clearance on 1997-02-06 under 510(k) number K964614. 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 ULTRAFERA WOUND DRESSING?

ULTRAFERA WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1997-02-06. The listed applicant is American White Cross, Inc.. The 510(k) number is K964614.

When did ULTRAFERA WOUND DRESSING receive FDA 510(k) clearance?

ULTRAFERA WOUND DRESSING received FDA 510(k) clearance on 1997-02-06, under 510(k) number K964614.

Who is the listed applicant for ULTRAFERA WOUND DRESSING?

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

What is the FDA product code for ULTRAFERA WOUND DRESSING?

The FDA product code for ULTRAFERA WOUND DRESSING is KMF.

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Other records listing American White Cross, 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.

K962400AIR MAX EXTERNAL NASAL DILATOR STRIPK894802AWC BUTTERFLY WOUND CLOSURESK854809WHITE CROSS STERILE PAD 4IN. X 4IN.K853558DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZK853334NON-ADHERA ADHESIVE PAD 3X4K852412NON-ADHERENT PAD

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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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