The following data is part of a premarket notification filed by Limestone Technologies Inc. with the FDA for Preftest Professional Suite.
| Device ID | K052929 |
| 510k Number | K052929 |
| Device Name: | PREFTEST PROFESSIONAL SUITE |
| Classification | Monitor, Penile Tumescence |
| Applicant | LIMESTONE TECHNOLOGIES INC. 4 INNOVATION DRIVE Dundas, CA L9h 7p3 |
| Contact | Nancy Ruth |
| Correspondent | Nancy Ruth LIMESTONE TECHNOLOGIES INC. 4 INNOVATION DRIVE Dundas, CA L9h 7p3 |
| Product Code | LIL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-19 |
| Decision Date | 2006-04-26 |
| Summary: | summary |