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 | K020969 |
510k Number | K020969 |
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 | 2002-03-26 |
Decision Date | 2002-06-05 |
Summary: | summary |