510(k) K030879

Device: VERITAS COLLAGEN MATRIX
Applicant: SYNOVIS SURGICAL INNOVATIONS
510(k) number: K030879
Product code: OXE
Decision: Substantially Equivalent (SESE)
Decision date: 2003-04-24
Date received: 2003-03-20
Regulation: 878.3300
Classification name: Mesh, Surgical, Collagen, 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: ANGELA MALLERY
Address: 2575 University Ave. St. Paul MN US 55114 55114

FDA Registration Numbers#

2183620
3012448339
1000393132
3004464325
2530154
3009882464
3010155661
1416980
2030598
3009504230
1047843
3010400367
2183744
3008868758

Source Documents#

Other 510(k) Records For Product Code OXE #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K170945	Biodesign Staple Line Reinforcement	Cook Biotech Incorporated	2017-04-28
K153364	Kerecis SecureMesh	Kerecis Limited	2016-08-19
K022044	SURGISIS STAPLE LINE REINFORCEMENT	Cook Biotech, Inc.	2002-08-23

Legacy Summary#

summary

FDA Review#

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