The following data is part of a premarket notification filed by Prosurg, Inc. with the FDA for Sensation -vacuum Assist Devices.
| Device ID | K000124 |
| 510k Number | K000124 |
| Device Name: | SENSATION -VACUUM ASSIST DEVICES |
| Classification | Device, External Penile Rigidity |
| Applicant | PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | Lee Bui |
| Correspondent | Lee Bui PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-18 |
| Decision Date | 2000-07-10 |