510(k) K982403
- Device
- BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
- Applicant
- BRENNEN MEDICAL, INC.
- 510(k) number
- K982403
- Product code
- PAG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-22
- Date received
- 1998-07-10
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- Medical specialty
- General & Plastic Surgery
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH B HERLAND
- Address
- 1290 Hammond Rd. St. Paul MN US 55110 55110
FDA Registration Numbers#
- 1048735
- 1018233
- 2530154
- 1000393132
- 1835959
- 1047843
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PAG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K090688 | COOK UROLOGICAL GRAFT | Cook Biotech, Inc. | 2009-07-10 |
| K050445 | AMS COLLAGEN DERMAL MATRIX | American Medical Systems, Inc. | 2005-06-17 |
| K042949 | PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) | C.R. Bard, Inc. | 2004-11-09 |
| K031295 | BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM | C.R. Bard, Inc. | 2003-05-15 |
| K030460 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Brennen Medical, Inc. | 2003-03-07 |
| K020654 | STRATASIS SLING KIT | Cook Biotech, Inc. | 2002-04-09 |
| K993459 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Advanced Uroscience, Inc. | 1999-11-05 |
| K992159 | SURGISIS SLING | Cook Biotech, Inc. | 1999-09-23 |
Legacy Summary#
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FDA Review#
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