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FDA 510(k)

REVERSIBLE HYDROCOLLOID IMPRESSION

K-Number: K811020 · 1981-05-05

ApplicantKottler Laboratories
Decision Date1981-05-05
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REVERSIBLE HYDROCOLLOID IMPRESSION is the device name listed in this FDA 510(k) record. The listed applicant is Kottler Laboratories. It received FDA 510(k) clearance on 1981-05-05 under 510(k) number K811020. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVERSIBLE HYDROCOLLOID IMPRESSION?

REVERSIBLE HYDROCOLLOID IMPRESSION is a medical device that received FDA 510(k) clearance on 1981-05-05. The listed applicant is Kottler Laboratories. The 510(k) number is K811020.

When did REVERSIBLE HYDROCOLLOID IMPRESSION receive FDA 510(k) clearance?

REVERSIBLE HYDROCOLLOID IMPRESSION received FDA 510(k) clearance on 1981-05-05, under 510(k) number K811020.

Who is the listed applicant for REVERSIBLE HYDROCOLLOID IMPRESSION?

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

What is the FDA product code for REVERSIBLE HYDROCOLLOID IMPRESSION?

The FDA product code for REVERSIBLE HYDROCOLLOID IMPRESSION is ELW.

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Related Devices (Code: ELW)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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