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FDA 510(k)

APPLICATOR, LEE IMPRESSION

K-Number: K781977 · 1978-12-20

ApplicantLee Pharmaceuticals
Decision Date1978-12-20
Product CodeEID
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

APPLICATOR, LEE IMPRESSION is the device name listed in this FDA 510(k) record. The listed applicant is Lee Pharmaceuticals. It received FDA 510(k) clearance on 1978-12-20 under 510(k) number K781977. The device is classified under product code EID. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APPLICATOR, LEE IMPRESSION?

APPLICATOR, LEE IMPRESSION is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is Lee Pharmaceuticals. The 510(k) number is K781977.

When did APPLICATOR, LEE IMPRESSION receive FDA 510(k) clearance?

APPLICATOR, LEE IMPRESSION received FDA 510(k) clearance on 1978-12-20, under 510(k) number K781977.

Who is the listed applicant for APPLICATOR, LEE IMPRESSION?

The FDA 510(k) record lists Lee Pharmaceuticals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APPLICATOR, LEE IMPRESSION?

The FDA product code for APPLICATOR, LEE IMPRESSION is EID.

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Other records listing Lee Pharmaceuticals 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.

K924378RESTOBOND 4K912256PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERTK900809LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETSK894315RESTOBOND 3/DENTIN-ENAMEL BONDING AGENTK881903PROSTHODENT VLK873123LEE COMPOSITE INLAY SYSTEM

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Related Devices (Code: EID)

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.

K941431BONE GRAFT DELIVERY SYRINGESBio-Interfaces, Inc.K913974ACCESS IMPRESSION BARRELCentrix, Inc.K873153CAULK'S VPS CARTRIDGE SYSTEMDentsply Intl.K871937IMPRESSION SYRINGEDentsply Intl.K863998COLTENE JET-MIXERColtene, Inc.K853282CENTRIX RIBBON TUBESCentrix, Inc.

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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