The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Avaulta Support System/avaulta Plus Biosynthetic Support System.
| Device ID | K063712 |
| 510k Number | K063712 |
| Device Name: | AVAULTA 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 | John C Knorpp |
| Correspondent | John C Knorpp C.R. BARD, INC. 13183 HARLAND DRIVE Covington, GA 30014 -6421 |
| Product Code | OTP |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-14 |
| Decision Date | 2007-03-12 |
| Summary: | summary |