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FDA 510(k)

SILICONE TISSUE EXPANDER

K-Number: K070303 · 2007-06-22

Decision Date2007-06-22
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

SILICONE TISSUE EXPANDER is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Surgical Products. It received FDA 510(k) clearance on 2007-06-22 under 510(k) number K070303. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE TISSUE EXPANDER?

SILICONE TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 2007-06-22. The listed applicant is Specialty Surgical Products. The 510(k) number is K070303.

When did SILICONE TISSUE EXPANDER receive FDA 510(k) clearance?

SILICONE TISSUE EXPANDER received FDA 510(k) clearance on 2007-06-22, under 510(k) number K070303.

Who is the listed applicant for SILICONE TISSUE EXPANDER?

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

What is the FDA product code for SILICONE TISSUE EXPANDER?

The FDA product code for SILICONE TISSUE EXPANDER is LCJ.

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.

Related Devices (Code: LCJ)

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.

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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