Tutopatch, Tutomesh, Models 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358

Q: What is the product code of K091142?

The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.

FDA 510(k) K091142 · Rti Biologics, Inc.

Substantially Equivalent

510(k) numberK091142

Submission

Device name: Tutopatch, Tutomesh, Models 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
Applicant: Rti Biologics, Inc.
Alachua, FL, US
Received: April 20, 2009
Decision date: August 31, 2009
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FTM – Mesh, Surgical
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.3300
Specialty: General, Plastic Surgery
Implant: Yes

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Questions and answers

When was Tutopatch, Tutomesh, Models 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 cleared by the FDA?

Tutopatch, Tutomesh, Models 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 (K091142) received a 510(k) decision of Substantially Equivalent on August 31, 2009, 133 days after the submission was received.

What is the product code of K091142?

The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.