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FDA 510(k)

BIODERM CALCIUM ALGINATE DRESSING

K-Number: K980451 · 1998-04-09

ApplicantBioderm, Inc.
Decision Date1998-04-09
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIODERM CALCIUM ALGINATE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Bioderm, Inc.. It received FDA 510(k) clearance on 1998-04-09 under 510(k) number K980451. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BIODERM CALCIUM ALGINATE DRESSING?

BIODERM CALCIUM ALGINATE DRESSING is a medical device that received FDA 510(k) clearance on 1998-04-09. The listed applicant is Bioderm, Inc.. The 510(k) number is K980451.

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

BIODERM CALCIUM ALGINATE DRESSING received FDA 510(k) clearance on 1998-04-09, under 510(k) number K980451.

Who is the listed applicant for BIODERM CALCIUM ALGINATE DRESSING?

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

What is the FDA product code for BIODERM CALCIUM ALGINATE DRESSING?

The FDA product code for BIODERM CALCIUM ALGINATE DRESSING is KMF.

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Other records listing Bioderm, 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.

K990955MODIFICATION OF:BIODERM FOAM WOUND DRESSINGK982778BIODERM FOAM WOUND DRESSINGK982939BTF THIN FILM WOUND DRESSINGK973429BIODERM FOAM WOUND DRESSINGK963950BIODERM EID MALE EXTERNAL INCONTINENCE DEVICEK963602BIODERM PVP FOAM 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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