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FDA 510(k)

DERMATEC ZONE TRANSPARENT DRESSING

K-Number: K863578 · 1986-11-25

ApplicantDermatec, Inc.
Decision Date1986-11-25
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

DERMATEC ZONE TRANSPARENT DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Dermatec, Inc.. It received FDA 510(k) clearance on 1986-11-25 under 510(k) number K863578. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DERMATEC ZONE TRANSPARENT DRESSING?

DERMATEC ZONE TRANSPARENT DRESSING is a medical device that received FDA 510(k) clearance on 1986-11-25. The listed applicant is Dermatec, Inc.. The 510(k) number is K863578.

When did DERMATEC ZONE TRANSPARENT DRESSING receive FDA 510(k) clearance?

DERMATEC ZONE TRANSPARENT DRESSING received FDA 510(k) clearance on 1986-11-25, under 510(k) number K863578.

Who is the listed applicant for DERMATEC ZONE TRANSPARENT DRESSING?

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

What is the FDA product code for DERMATEC ZONE TRANSPARENT DRESSING?

The FDA product code for DERMATEC ZONE TRANSPARENT DRESSING is NAD.

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.

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Other records listing Dermatec, 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.

K863580DERMATEC TRANSPARENT FILM DRESSINGK863379DERMATEC BURN PADSK833638DERMATEX STERILE FINGER BANDAGE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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