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FDA 510(k)

PONTOR LFC

K-Number: K935387 · 1994-01-06

ApplicantMetalor
Decision Date1994-01-06
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PONTOR LFC is the device name listed in this FDA 510(k) record. The listed applicant is Metalor. It received FDA 510(k) clearance on 1994-01-06 under 510(k) number K935387. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PONTOR LFC?

PONTOR LFC is a medical device that received FDA 510(k) clearance on 1994-01-06. The listed applicant is Metalor. The 510(k) number is K935387.

When did PONTOR LFC receive FDA 510(k) clearance?

PONTOR LFC received FDA 510(k) clearance on 1994-01-06, under 510(k) number K935387.

Who is the listed applicant for PONTOR LFC?

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

What is the FDA product code for PONTOR LFC?

The FDA product code for PONTOR LFC is EJT.

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 Metalor 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.

K944572V-DELTA N (V-DELTA LOY), AUROFLUID 2PFK935388CERAPALL 4CF

Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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