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FDA 510(k)

ALBA DRY BURN DRESSING

K-Number: K850904 · 1985-04-17

ApplicantAlba Health Care
Decision Date1985-04-17
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALBA DRY BURN DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Alba Health Care. It received FDA 510(k) clearance on 1985-04-17 under 510(k) number K850904. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBA DRY BURN DRESSING?

ALBA DRY BURN DRESSING is a medical device that received FDA 510(k) clearance on 1985-04-17. The listed applicant is Alba Health Care. The 510(k) number is K850904.

When did ALBA DRY BURN DRESSING receive FDA 510(k) clearance?

ALBA DRY BURN DRESSING received FDA 510(k) clearance on 1985-04-17, under 510(k) number K850904.

Who is the listed applicant for ALBA DRY BURN DRESSING?

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

What is the FDA product code for ALBA DRY BURN DRESSING?

The FDA product code for ALBA DRY BURN DRESSING is NAD.

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Other records listing Alba Health Care 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.

K864689ALBA HEALTH CARE IODOFORM PACKING STRIPK861154ALBA HEALTH CARE PLAIN PACKING STRIPK851918INFANT PHOTOTHERAPY MASKK850881ALBA DRY BURN PADK850241ALBA HEALTH CARE NON-ADHERING DRESSINGK812904STERILE ORTHOPEDIC STOCKINETTE

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Related Devices (Code: NAD)

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.

K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.K102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEALSam Medical ProductsK091133APLION TOPICAL CARE SYSTEMAplion Medical,LlcK072560ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)Teikoku Pharma USA, Inc.K080524CENTURION SORBAVIEW OTCTri-State Hospital Supply Corp.K060046DERMASTREAMEnzysurge , Ltd.

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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