The following data is part of a premarket notification filed by Vacurect Manufacturing (pty) Ltd. with the FDA for Vacurect Vacuum Constriction Device.
| Device ID | K032776 |
| 510k Number | K032776 |
| Device Name: | VACURECT VACUUM CONSTRICTION DEVICE |
| Classification | Device, External Penile Rigidity |
| Applicant | VACURECT MANUFACTURING (PTY) LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane VACURECT MANUFACTURING (PTY) LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-08 |
| Decision Date | 2003-10-03 |
| Summary: | summary |