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FDA 510(k)

JEL-40 (CODE NAME RD-0430)

K-Number: K964158 · 1996-12-13

ApplicantJelenko Co.
Decision Date1996-12-13
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JEL-40 (CODE NAME RD-0430) is the device name listed in this FDA 510(k) record. The listed applicant is Jelenko Co.. It received FDA 510(k) clearance on 1996-12-13 under 510(k) number K964158. 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-40 (CODE NAME RD-0430)?

JEL-40 (CODE NAME RD-0430) is a medical device that received FDA 510(k) clearance on 1996-12-13. The listed applicant is Jelenko Co.. The 510(k) number is K964158.

When did JEL-40 (CODE NAME RD-0430) receive FDA 510(k) clearance?

JEL-40 (CODE NAME RD-0430) received FDA 510(k) clearance on 1996-12-13, under 510(k) number K964158.

Who is the listed applicant for JEL-40 (CODE NAME RD-0430)?

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

What is the FDA product code for JEL-40 (CODE NAME RD-0430)?

The FDA product code for JEL-40 (CODE NAME RD-0430) is EJT.

Other records listing Jelenko 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.

K010416HERACERAM 75K003603BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HEK984164JELBOND NPK930762SUPERSTARK912194PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USEK912195PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE

View all 12 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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