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FDA 510(k)

FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING

K-Number: K963656 · 1996-11-12

ApplicantAdri
Decision Date1996-11-12
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Adri. It received FDA 510(k) clearance on 1996-11-12 under 510(k) number K963656. 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 FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING?

FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1996-11-12. The listed applicant is Adri. The 510(k) number is K963656.

When did FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING receive FDA 510(k) clearance?

FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING received FDA 510(k) clearance on 1996-11-12, under 510(k) number K963656.

Who is the listed applicant for FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING?

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

What is the FDA product code for FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING?

The FDA product code for FOAM CALCIUM ALIGINATE TOPICAL WOUND 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Adri 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.

K041268SILVERSITE OR CALGITROLK011618CALGITROL AG SILVER ALGINATE WOUND DRESSINGK000054FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGENK940404ALGINATE FIBER TOPICAL WOUND DRESSINGK870383ALGINATE WOOL FIBER

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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