FDA 510(k)

HP-3

K-Number: K923718 · 1993-03-05

Decision Date1993-03-05

Product CodeEJT

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

HP-3 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 1993-03-05 under 510(k) number K923718. 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 HP-3?

HP-3 is a medical device that received FDA 510(k) clearance on 1993-03-05. The listed applicant is J.F. Jelenko & Co., Inc.. The 510(k) number is K923718.

When did HP-3 receive FDA 510(k) clearance?

HP-3 received FDA 510(k) clearance on 1993-03-05, under 510(k) number K923718.

Who is the listed applicant for HP-3?

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 HP-3?

The FDA product code for HP-3 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.