FDA 510(k)

AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**

K-Number: K952748 · 1995-08-10

ApplicantUnited States Surgical, A Division of Tyco Healthc

Decision Date1995-08-10

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1995-08-10 under 510(k) number K952748. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**?

AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** is a medical device that received FDA 510(k) clearance on 1995-08-10. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K952748.

When did AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** receive FDA 510(k) clearance?

AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** received FDA 510(k) clearance on 1995-08-10, under 510(k) number K952748.

Who is the listed applicant for AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**?

The FDA product code for AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** is LJT.

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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.