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FDA 510(k)

JAW BLOCKER

K-Number: K896745 · 1989-12-14

ApplicantPlastic Engineered Products Co.
Decision Date1989-12-14
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

JAW BLOCKER is the device name listed in this FDA 510(k) record. The listed applicant is Plastic Engineered Products Co.. It received FDA 510(k) clearance on 1989-12-14 under 510(k) number K896745. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAW BLOCKER?

JAW BLOCKER is a medical device that received FDA 510(k) clearance on 1989-12-14. The listed applicant is Plastic Engineered Products Co.. The 510(k) number is K896745.

When did JAW BLOCKER receive FDA 510(k) clearance?

JAW BLOCKER received FDA 510(k) clearance on 1989-12-14, under 510(k) number K896745.

Who is the listed applicant for JAW BLOCKER?

The FDA 510(k) record lists Plastic Engineered Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAW BLOCKER?

The FDA product code for JAW BLOCKER is JXL.

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 Plastic Engineered Products Co. 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.

K871879SOFSWAB

Related Devices (Code: JXL)

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.

K221469PATI (Protector Against Tongue Injury)Neurovice, LLCK201309ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta CorporationK172978SurgeoBiteSurgovations, LLCK050188EPIGUARDEpisafe Medical Devices, Ltd.K992269VENTIL-A ORAL PROTECTORSomatics, Inc.K960663UNIVERSAL BITE BLOCKB&B Medical Technologies, Inc.

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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