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FDA 510(k)

BURNSHIELD TRAUMA DRESSING

K-Number: K921471 · 1993-04-20

ApplicantLevtrade Intl. (Pty) , Ltd.
Decision Date1993-04-20
Product CodeFPY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BURNSHIELD TRAUMA DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Levtrade Intl. (Pty) , Ltd.. It received FDA 510(k) clearance on 1993-04-20 under 510(k) number K921471. The device is classified under product code FPY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BURNSHIELD TRAUMA DRESSING?

BURNSHIELD TRAUMA DRESSING is a medical device that received FDA 510(k) clearance on 1993-04-20. The listed applicant is Levtrade Intl. (Pty) , Ltd.. The 510(k) number is K921471.

When did BURNSHIELD TRAUMA DRESSING receive FDA 510(k) clearance?

BURNSHIELD TRAUMA DRESSING received FDA 510(k) clearance on 1993-04-20, under 510(k) number K921471.

Who is the listed applicant for BURNSHIELD TRAUMA DRESSING?

The FDA 510(k) record lists Levtrade Intl. (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BURNSHIELD TRAUMA DRESSING?

The FDA product code for BURNSHIELD TRAUMA DRESSING is FPY.

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 Levtrade Intl. (Pty) , Ltd. 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.

K943728BURNFREE BURNSOOTHE HYDROGELK943470BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTSK921470BURNSHIELD FIRE BLANKET

Related Devices (Code: FPY)

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.

K930759CP & S STERILE BURN SHEETConsolidated Products & Services, Inc.K926290BURN SHEETGam Industries, Inc.K921470BURNSHIELD FIRE BLANKETLevtrade Intl. (Pty) , Ltd.K900442BURNS CASUALTY SHEET BURN ROLLPilgrim Medical ServicesK900443BURNS CASUALTY SHEET LIMB WRAPPilgrim Medical ServicesK900441BURNS CASUALTY SHEETPilgrim Medical Services

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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