FDA 510(k)

COE-SIL

K-Number: K792428 · 1980-01-23

Decision Date1980-01-23

Product CodeLDG

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

COE-SIL is the device name listed in this FDA 510(k) record. The listed applicant is Coe Laboratories, Inc.. It received FDA 510(k) clearance on 1980-01-23 under 510(k) number K792428. The device is classified under product code LDG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COE-SIL?

COE-SIL is a medical device that received FDA 510(k) clearance on 1980-01-23. The listed applicant is Coe Laboratories, Inc.. The 510(k) number is K792428.

When did COE-SIL receive FDA 510(k) clearance?

COE-SIL received FDA 510(k) clearance on 1980-01-23, under 510(k) number K792428.

Who is the listed applicant for COE-SIL?

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

What is the FDA product code for COE-SIL?

The FDA product code for COE-SIL is LDG.

Other records listing Coe Laboratories, 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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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.