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FDA 510(k)

JEL BIOS PURE

K-Number: K002645 · 2000-10-19

ApplicantJ.F. Jelenko & Co., Inc.
Decision Date2000-10-19
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JEL BIOS PURE 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 2000-10-19 under 510(k) number K002645. 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 JEL BIOS PURE?

JEL BIOS PURE is a medical device that received FDA 510(k) clearance on 2000-10-19. The listed applicant is J.F. Jelenko & Co., Inc.. The 510(k) number is K002645.

When did JEL BIOS PURE receive FDA 510(k) clearance?

JEL BIOS PURE received FDA 510(k) clearance on 2000-10-19, under 510(k) number K002645.

Who is the listed applicant for JEL BIOS PURE?

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 JEL BIOS PURE?

The FDA product code for JEL BIOS PURE is EJT.

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-20K002993HERACERAMK002222RD-2104K001360SIGNUMK001260ALLROUND 55 LFK001196JEL BIOS 90 (CODE NAME RD-2401)

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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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