The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support System.
| Device ID | K083839 |
| 510k Number | K083839 |
| Device Name: | AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | C.R. BARD, INC. 13183 HARLAND DRIVE Covington, GA 30014 -6421 |
| Contact | Terri Morris |
| Correspondent | Terri Morris C.R. BARD, INC. 13183 HARLAND DRIVE Covington, GA 30014 -6421 |
| Product Code | OTP |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-23 |
| Decision Date | 2009-01-15 |
| Summary: | summary |