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FDA 510(k)

MONOGRAM I

K-Number: K895051 · 1989-12-18

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

Device Summary

MONOGRAM I 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 K895051. 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 I?

MONOGRAM I 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 K895051.

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

MONOGRAM I received FDA 510(k) clearance on 1989-12-18, under 510(k) number K895051.

Who is the listed applicant for MONOGRAM I?

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 I?

The FDA product code for MONOGRAM I is EJT.

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Other records listing Leach and Dillon 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.

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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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