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FDA 510(k)

FLASH GUARD PLASTIC VERSION

K-Number: K844286 · 1984-11-19

ApplicantSparco, Inc.
Decision Date1984-11-19
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLASH GUARD PLASTIC VERSION is the device name listed in this FDA 510(k) record. The listed applicant is Sparco, Inc.. It received FDA 510(k) clearance on 1984-11-19 under 510(k) number K844286. The device is classified under product code FSM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLASH GUARD PLASTIC VERSION?

FLASH GUARD PLASTIC VERSION is a medical device that received FDA 510(k) clearance on 1984-11-19. The listed applicant is Sparco, Inc.. The 510(k) number is K844286.

When did FLASH GUARD PLASTIC VERSION receive FDA 510(k) clearance?

FLASH GUARD PLASTIC VERSION received FDA 510(k) clearance on 1984-11-19, under 510(k) number K844286.

Who is the listed applicant for FLASH GUARD PLASTIC VERSION?

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

What is the FDA product code for FLASH GUARD PLASTIC VERSION?

The FDA product code for FLASH GUARD PLASTIC VERSION is FSM.

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 Sparco, 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.

K884041MASTER-GUARDK863964LIMB-GUARDK850268SPARCO SCOPE GUARDK850267SPARCO PIGGY-BACK POLE-INTRAVENOUS TRANSPORT POLEK841669FLASH GUARD

Related Devices (Code: FSM)

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.

K971217INSTRUMENT TRAY LINERGeneral Hospital Supply Corp.K962328SINGLE USE INSTRUMENT TRAYMedcare Medical Group, Inc.K944025SURGICAL INSTRUMENT TRAYRiley Medical, Inc.K912106ARTHROSCOPY TRAYMedical Device Inspection Co., Inc.K912053OPEN HEART TRAYMedical Device Inspection Co., Inc.K912052HEART CATH TRAYMedical Device Inspection Co., Inc.

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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