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FDA 510(k)

SUNCAST D-KF

K-Number: K923719 · 1993-03-05

ApplicantJ.F. Jelenko & Co., Inc.
Decision Date1993-03-05
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUNCAST D-KF 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 K923719. 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 SUNCAST D-KF?

SUNCAST D-KF 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 K923719.

When did SUNCAST D-KF receive FDA 510(k) clearance?

SUNCAST D-KF received FDA 510(k) clearance on 1993-03-05, under 510(k) number K923719.

Who is the listed applicant for SUNCAST D-KF?

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 SUNCAST D-KF?

The FDA product code for SUNCAST D-KF 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.

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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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