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FDA 510(k)

JELENKO NO.1 (CODE NAME RD-0601)

K-Number: K970068 · 1997-03-24

ApplicantJ.F. Jelenko & Co., Inc.
Decision Date1997-03-24
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JELENKO NO.1 (CODE NAME RD-0601) 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 1997-03-24 under 510(k) number K970068. 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 JELENKO NO.1 (CODE NAME RD-0601)?

JELENKO NO.1 (CODE NAME RD-0601) is a medical device that received FDA 510(k) clearance on 1997-03-24. The listed applicant is J.F. Jelenko & Co., Inc.. The 510(k) number is K970068.

When did JELENKO NO.1 (CODE NAME RD-0601) receive FDA 510(k) clearance?

JELENKO NO.1 (CODE NAME RD-0601) received FDA 510(k) clearance on 1997-03-24, under 510(k) number K970068.

Who is the listed applicant for JELENKO NO.1 (CODE NAME RD-0601)?

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 JELENKO NO.1 (CODE NAME RD-0601)?

The FDA product code for JELENKO NO.1 (CODE NAME RD-0601) is EJT.

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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-20K002993HERACERAMK002645JEL BIOS PUREK002222RD-2104K001360SIGNUMK001260ALLROUND 55 LF

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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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