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FDA 510(k)

MONOGRAM III

K-Number: K895065 · 1989-12-18

ApplicantLeach and Dillon Co., Inc.
Decision Date1989-12-18
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MONOGRAM III is the device name listed in this FDA 510(k) record. The listed applicant is Leach and Dillon Co., Inc.. It received FDA 510(k) clearance on 1989-12-18 under 510(k) number K895065. 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 MONOGRAM III?

MONOGRAM III is a medical device that received FDA 510(k) clearance on 1989-12-18. The listed applicant is Leach and Dillon Co., Inc.. The 510(k) number is K895065.

When did MONOGRAM III receive FDA 510(k) clearance?

MONOGRAM III received FDA 510(k) clearance on 1989-12-18, under 510(k) number K895065.

Who is the listed applicant for MONOGRAM III?

The FDA 510(k) record lists Leach and Dillon Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOGRAM III?

The FDA product code for MONOGRAM III is EJT.

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Other records listing Leach and Dillon Co., Inc. as applicant

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Related Devices (Code: EJT)

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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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