The following data is part of a premarket notification filed by Erecxel Enterprises with the FDA for Erecxel Adjustable Penile Bands, Contrex Adjustable Penile Bands.
| Device ID | K993343 |
| 510k Number | K993343 |
| Device Name: | ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS |
| Classification | Device, External Penile Rigidity |
| Applicant | ERECXEL ENTERPRISES 3249 SAN FEMANDO RD. Los Angeles, CA 90065 |
| Contact | Pacifico R Burgos |
| Correspondent | Pacifico R Burgos ERECXEL ENTERPRISES 3249 SAN FEMANDO RD. Los Angeles, CA 90065 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-05 |
| Decision Date | 2000-03-20 |
| Summary: | summary |