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FDA 510(k)

COE-LITE POLYMERIZATION UNIT

K-Number: K844325 · 1984-12-11

ApplicantCoe Laboratories, Inc.
Decision Date1984-12-11
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COE-LITE POLYMERIZATION UNIT 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 1984-12-11 under 510(k) number K844325. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COE-LITE POLYMERIZATION UNIT?

COE-LITE POLYMERIZATION UNIT is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Coe Laboratories, Inc.. The 510(k) number is K844325.

When did COE-LITE POLYMERIZATION UNIT receive FDA 510(k) clearance?

COE-LITE POLYMERIZATION UNIT received FDA 510(k) clearance on 1984-12-11, under 510(k) number K844325.

Who is the listed applicant for COE-LITE POLYMERIZATION UNIT?

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-LITE POLYMERIZATION UNIT?

The FDA product code for COE-LITE POLYMERIZATION UNIT is EBZ.

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Other records listing Coe Laboratories, Inc. as applicant

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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.

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