FDA 510(k)

SILICONE

K-Number: K844377 · 1985-03-18

Decision Date1985-03-18

Product Code

DecisionSubstantially Equivalent

Device Summary

SILICONE is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1985-03-18 under 510(k) number K844377. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE?

SILICONE is a medical device that received FDA 510(k) clearance on 1985-03-18. The listed applicant is Treace Medical, Inc.. The 510(k) number is K844377.

When did SILICONE receive FDA 510(k) clearance?

SILICONE received FDA 510(k) clearance on 1985-03-18, under 510(k) number K844377.

Who is the listed applicant for SILICONE?

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

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Other records listing Treace Medical, 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.