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FDA 510(k)

BURNS CASUALTY SHEET BURN ROLL

K-Number: K900442 · 1990-07-03

ApplicantPilgrim Medical Services
Decision Date1990-07-03
Product CodeFPY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BURNS CASUALTY SHEET BURN ROLL is the device name listed in this FDA 510(k) record. The listed applicant is Pilgrim Medical Services. It received FDA 510(k) clearance on 1990-07-03 under 510(k) number K900442. 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 BURNS CASUALTY SHEET BURN ROLL?

BURNS CASUALTY SHEET BURN ROLL is a medical device that received FDA 510(k) clearance on 1990-07-03. The listed applicant is Pilgrim Medical Services. The 510(k) number is K900442.

When did BURNS CASUALTY SHEET BURN ROLL receive FDA 510(k) clearance?

BURNS CASUALTY SHEET BURN ROLL received FDA 510(k) clearance on 1990-07-03, under 510(k) number K900442.

Who is the listed applicant for BURNS CASUALTY SHEET BURN ROLL?

The FDA 510(k) record lists Pilgrim Medical Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BURNS CASUALTY SHEET BURN ROLL?

The FDA product code for BURNS CASUALTY SHEET BURN ROLL 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 Pilgrim Medical Services 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.

K900443BURNS CASUALTY SHEET LIMB WRAPK900441BURNS CASUALTY SHEET

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.K921470BURNSHIELD FIRE BLANKETLevtrade Intl. (Pty) , Ltd.K921471BURNSHIELD TRAUMA DRESSINGLevtrade Intl. (Pty) , Ltd.K926290BURN SHEETGam Industries, Inc.K900443BURNS CASUALTY SHEET LIMB WRAPPilgrim Medical ServicesK900441BURNS CASUALTY SHEETPilgrim Medical Services

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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