The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Slide One.
| Device ID | K090009 |
| 510k Number | K090009 |
| Device Name: | THD SLIDE ONE |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | THD SPA 5 TIMBER LN. North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell THD SPA 5 TIMBER LN. North Reading, MA 01864 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-02 |
| Decision Date | 2009-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033737710730 | K090009 | 000 |
| 18033737710774 | K090009 | 000 |
| 18033737710781 | K090009 | 000 |