510(k) K955364

Device: SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Applicant: W.L. GORE & ASSOCIATES,INC
510(k) number: K955364
Product code: OXD
Decision: Substantially Equivalent (SESE)
Decision date: 1996-02-01
Date received: 1995-11-22
Regulation: 878.3300
Classification name: Mesh, Surgical, Non-absorbable, Staple Line Reinforcement
Medical specialty: General & Plastic Surgery
Review panel: General & Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: R. LARRY PRATT
Address: 3750 W. Kiltie Ln. P. O. Box 500 Flagstaff AZ US 86002 86002

Source Documents#

Other 510(k) Records For Product Code OXD #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K010936	MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL	W. L. Gore & Associates, Inc.	2001-05-21
K001789	SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL	W. L. Gore & Associates, Inc.	2000-07-06

Legacy Summary#

summary

FDA Review#

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