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FDA 510(k)

DERMATEC TRANSPARENT FILM DRESSING

K-Number: K863580 · 1986-12-31

ApplicantDermatec, Inc.
Decision Date1986-12-31
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

DERMATEC TRANSPARENT FILM 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 1986-12-31 under 510(k) number K863580. 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 TRANSPARENT FILM DRESSING?

DERMATEC TRANSPARENT FILM DRESSING is a medical device that received FDA 510(k) clearance on 1986-12-31. The listed applicant is Dermatec, Inc.. The 510(k) number is K863580.

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

DERMATEC TRANSPARENT FILM DRESSING received FDA 510(k) clearance on 1986-12-31, under 510(k) number K863580.

Who is the listed applicant for DERMATEC TRANSPARENT FILM 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 TRANSPARENT FILM DRESSING?

The FDA product code for DERMATEC TRANSPARENT FILM 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.

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 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.

K863578DERMATEC ZONE TRANSPARENT 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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