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FDA 510(k)

ENTELLAN

K-Number: K800847 · 1980-05-08

ApplicantMcb Manufacturing Chemists, Inc.
Decision Date1980-05-08
Product CodeKEP
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

ENTELLAN is the device name listed in this FDA 510(k) record. The listed applicant is Mcb Manufacturing Chemists, Inc.. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800847. The device is classified under product code KEP. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTELLAN?

ENTELLAN is a medical device that received FDA 510(k) clearance on 1980-05-08. The listed applicant is Mcb Manufacturing Chemists, Inc.. The 510(k) number is K800847.

When did ENTELLAN receive FDA 510(k) clearance?

ENTELLAN received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800847.

Who is the listed applicant for ENTELLAN?

The FDA 510(k) record lists Mcb Manufacturing Chemists, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTELLAN?

The FDA product code for ENTELLAN is KEP.

Related Clinical Trials

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Other records listing Mcb Manufacturing Chemists, 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.

K801212WRIGHTS RAPID STAINK792026WRIGHTS RAPID STAINK791929WRIGHTS RAPID STAINK782066EXETRELUT

Related Devices (Code: KEP)

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.

K830659CLEARIUM, MOUNTING MEDIUMSurgipath Medical Industries, Inc.K810323ACRYTOL, MOUNTING MEDIUMSurgipath

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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