The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Erecaid Classic System; Erecaid Esteem Manual System; Erecaid Esteem Battery System.
| Device ID | K020082 |
| 510k Number | K020082 |
| Device Name: | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM |
| Classification | Device, External Penile Rigidity |
| Applicant | ENDOCARE, INC. 6585 CITY WEST PKWY. Eden Prairie, MN 55344 |
| Contact | Chris Hadland |
| Correspondent | Chris Hadland ENDOCARE, INC. 6585 CITY WEST PKWY. Eden Prairie, MN 55344 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-10 |
| Decision Date | 2002-02-05 |
| Summary: | summary |