FDA 510(k)

JEL 96

K-Number: K944679 · 1994-11-07

Decision Date1994-11-07

Product CodeEJT

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

JEL 96 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 1994-11-07 under 510(k) number K944679. 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 96?

JEL 96 is a medical device that received FDA 510(k) clearance on 1994-11-07. The listed applicant is J.F. Jelenko & Co., Inc.. The 510(k) number is K944679.

When did JEL 96 receive FDA 510(k) clearance?

JEL 96 received FDA 510(k) clearance on 1994-11-07, under 510(k) number K944679.

Who is the listed applicant for JEL 96?

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 96?

The FDA product code for JEL 96 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-20 K002993HERACERAM K002645JEL BIOS PURE K002222RD-2104 K001360SIGNUM K001260ALLROUND 55 LF

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Related Devices (Code: EJT)

K052463PROMETAL HN86Prometal Technologies K041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KG K040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KG K040043NDX-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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.