FDA 510(k)

JEL 15

K-Number: K000532 · 2000-04-06

Decision Date2000-04-06

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

JEL 15 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 2000-04-06 under 510(k) number K000532. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JEL 15?

JEL 15 is a medical device that received FDA 510(k) clearance on 2000-04-06. The listed applicant is J.F. Jelenko & Co., Inc.. The 510(k) number is K000532.

When did JEL 15 receive FDA 510(k) clearance?

JEL 15 received FDA 510(k) clearance on 2000-04-06, under 510(k) number K000532.

Who is the listed applicant for JEL 15?

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 15?

The FDA product code for JEL 15 is EJS.

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: EJS)

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KG K022252STERNGOLD 1, MODEL 1127781Sterngold K022469ECO E4Wieland Dental + Technik GmbH & Co. KG K021367STERNGOLD 66, MODEL #1180230Sterngold K020194SIMIDUR KF PLUSWieland Dental + Technik GmbH & Co. KG

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.