The following data is part of a premarket notification filed by Ercons, Inc. with the FDA for Erco-ribbon.
| Device ID | K981343 |
| 510k Number | K981343 |
| Device Name: | ERCO-RIBBON |
| Classification | Device, External Penile Rigidity |
| Applicant | ERCONS, INC. 66 OVERLOOK TERRACE, SUITE 2E New York, NY 10040 |
| Contact | Yakov Altshuler |
| Correspondent | Yakov Altshuler ERCONS, INC. 66 OVERLOOK TERRACE, SUITE 2E New York, NY 10040 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-13 |
| Decision Date | 1998-11-24 |
| Summary: | summary |