Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16

FDA 510(k) K040835 · Pm Devices, Inc.

Substantially Equivalent

510(k) numberK040835

Submission

Device name
Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16
Applicant
Pm Devices, Inc.
Richmond, Bc, CA
Received
March 31, 2004
Decision date
June 15, 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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Questions and answers

When was Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16 cleared by the FDA?

Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16 (K040835) received a 510(k) decision of Substantially Equivalent on June 15, 2004, 76 days after the submission was received.

What is the product code of K040835?

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