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FDA 510(k)

MONOGRAM II

K-Number: K895064 · 1989-12-18

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

Device Summary

MONOGRAM II 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 K895064. 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 II?

MONOGRAM II 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 K895064.

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

MONOGRAM II received FDA 510(k) clearance on 1989-12-18, under 510(k) number K895064.

Who is the listed applicant for MONOGRAM II?

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 II?

The FDA product code for MONOGRAM II is EJT.

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Other records listing Leach and Dillon 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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