The following data is part of a premarket notification filed by Repro-med Systems, Inc. with the FDA for Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (penile Erection Program), Rely Vacuum Erection Dev).
| Device ID | K981506 |
| 510k Number | K981506 |
| Device Name: | RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) |
| Classification | Device, External Penile Rigidity |
| Applicant | REPRO-MED SYSTEMS, INC. 24 CARPENTER RD. Chester, NY 10918 |
| Contact | Andrew I Sealfon |
| Correspondent | Andrew I Sealfon REPRO-MED SYSTEMS, INC. 24 CARPENTER RD. Chester, NY 10918 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-27 |
| Decision Date | 1998-06-25 |
| Summary: | summary |