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FDA 510(k)

UNI-SITE

K-Number: K953018 · 1995-09-08

ApplicantTtl Medical
Decision Date1995-09-08
Product CodeMGP
DecisionSubstantially Equivalent

Device Summary

UNI-SITE is the device name listed in this FDA 510(k) record. The listed applicant is Ttl Medical. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K953018. The device is classified under product code MGP. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-SITE?

UNI-SITE is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Ttl Medical. The 510(k) number is K953018.

When did UNI-SITE receive FDA 510(k) clearance?

UNI-SITE received FDA 510(k) clearance on 1995-09-08, under 510(k) number K953018.

Who is the listed applicant for UNI-SITE?

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

What is the FDA product code for UNI-SITE?

The FDA product code for UNI-SITE is MGP.

Other records listing Ttl Medical as applicant

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: MGP)

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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