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FDA 510(k)

ORAL SPONGE

K-Number: K823136 · 1983-03-31

ApplicantAmisplint
Decision Date1983-03-31
Product Code
DecisionSubstantially Equivalent

Device Summary

ORAL SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Amisplint. It received FDA 510(k) clearance on 1983-03-31 under 510(k) number K823136. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAL SPONGE?

ORAL SPONGE is a medical device that received FDA 510(k) clearance on 1983-03-31. The listed applicant is Amisplint. The 510(k) number is K823136.

When did ORAL SPONGE receive FDA 510(k) clearance?

ORAL SPONGE received FDA 510(k) clearance on 1983-03-31, under 510(k) number K823136.

Who is the listed applicant for ORAL SPONGE?

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

Related Clinical Trials

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.

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