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FDA 510(k)

ALLROUND 55 LF

K-Number: K001260 · 2000-05-17

ApplicantJ.F. Jelenko & Co., Inc.
Decision Date2000-05-17
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALLROUND 55 LF is the device name listed in this FDA 510(k) record. The listed applicant is J.F. Jelenko & Co., Inc.. It received FDA 510(k) clearance on 2000-05-17 under 510(k) number K001260. 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 ALLROUND 55 LF?

ALLROUND 55 LF is a medical device that received FDA 510(k) clearance on 2000-05-17. The listed applicant is J.F. Jelenko & Co., Inc.. The 510(k) number is K001260.

When did ALLROUND 55 LF receive FDA 510(k) clearance?

ALLROUND 55 LF received FDA 510(k) clearance on 2000-05-17, under 510(k) number K001260.

Who is the listed applicant for ALLROUND 55 LF?

The FDA 510(k) record lists J.F. Jelenko & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALLROUND 55 LF?

The FDA product code for ALLROUND 55 LF is EJT.

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Other records listing J.F. Jelenko & Co., 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.

K012303JEL-20K002993HERACERAMK002645JEL BIOS PUREK002222RD-2104K001360SIGNUMK001196JEL BIOS 90 (CODE NAME RD-2401)

View all 55 devices →

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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