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FDA 510(k)

ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE

K-Number: K983833 · 1998-12-10

ApplicantWestaim Biomedical, Inc.
Decision Date1998-12-10
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Westaim Biomedical, Inc.. It received FDA 510(k) clearance on 1998-12-10 under 510(k) number K983833. 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 ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE?

ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE is a medical device that received FDA 510(k) clearance on 1998-12-10. The listed applicant is Westaim Biomedical, Inc.. The 510(k) number is K983833.

When did ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE receive FDA 510(k) clearance?

ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE received FDA 510(k) clearance on 1998-12-10, under 510(k) number K983833.

Who is the listed applicant for ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE?

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

What is the FDA product code for ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE?

The FDA product code for ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE is KMF.

Related Clinical Trials

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Other records listing Westaim Biomedical, 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.

K010447MODIFICATION TO ACTICOAT FOAM DRESSINGK002466ACTICOAT COMPOSITE DRESSINGK001519ACTICOAT 7 DRESSINGK992221ACTICOAT PRIMARY ANTIMICROBIAL DRESSINGK000051ACTICOAT FOAM DRESSING

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

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