Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10

Q: What is the product code of K033985?

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

FDA 510(k) K033985 · Pm Devices, Inc.

Substantially Equivalent

510(k) numberK033985

Submission

Device name: Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10
Applicant: Pm Devices, Inc.
Richmond, Bc, CA
Received: December 23, 2003
Decision date: June 4, 2004
Decision: Substantially Equivalent (SESE)
Type: Traditional 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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More from Geistlich Pharma AG

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K063556	Peripatch Endo-SleeveFTM · Traditional	03/20/2007SE
K040835	Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16FTM · Traditional	06/15/2004SE
K031948	Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16DXZ · Traditional	09/16/2003SE

Questions and answers

When was Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10 cleared by the FDA?

Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10 (K033985) received a 510(k) decision of Substantially Equivalent on June 4, 2004, 164 days after the submission was received.

What is the product code of K033985?

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