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FDA 510(k)

BENCHMARK-IV

K-Number: K971575 · 1997-06-04

ApplicantJ.F. Jelenko & Co., Inc.
Decision Date1997-06-04
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BENCHMARK-IV 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 1997-06-04 under 510(k) number K971575. 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 BENCHMARK-IV?

BENCHMARK-IV is a medical device that received FDA 510(k) clearance on 1997-06-04. The listed applicant is J.F. Jelenko & Co., Inc.. The 510(k) number is K971575.

When did BENCHMARK-IV receive FDA 510(k) clearance?

BENCHMARK-IV received FDA 510(k) clearance on 1997-06-04, under 510(k) number K971575.

Who is the listed applicant for BENCHMARK-IV?

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 BENCHMARK-IV?

The FDA product code for BENCHMARK-IV is EJT.

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Other records listing J.F. Jelenko & Co., Inc. as applicant

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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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