The following data is part of a premarket notification filed by Augmenta Llc with the FDA for Augmenta Penile Implant.
| Device ID | K200073 |
| 510k Number | K200073 |
| Device Name: | AugMENTA Penile Implant |
| Classification | Elastomer, Silicone Block |
| Applicant | Augmenta LLC 1315 St. Joesph Parkway, Suite 1700 Houston, TX 77002 |
| Contact | Robert J Cornell |
| Correspondent | Lisa L. Pritchard DUVAL & ASSOCIATES, P.A. 1820 MEDICAL ARTS BUILDING 825 NICOLLET MALL MINNEAPOLIS, MN 55402 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-14 |
| Decision Date | 2022-09-30 |