The following data is part of a premarket notification filed by Tactile Systems Technology Inc with the FDA for Entré Model Pd08-u.
| Device ID | K143185 |
| 510k Number | K143185 |
| Device Name: | Entré Model PD08-U |
| Classification | Sleeve, Limb, Compressible |
| Applicant | TACTILE SYSTEMS TECHNOLOGY INC 1331 Tyler St N.E Minneapolis, MN 55413 |
| Contact | Daniel G Chase |
| Correspondent | Daniel G Chase TACTILE SYSTEMS TECHNOLOGY INC 1331 Tyler St N.E Minneapolis, MN 55413 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-05 |
| Decision Date | 2015-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816305023343 | K143185 | 000 |
| 00816305020069 | K143185 | 000 |
| 00816305020052 | K143185 | 000 |
| 00816305020045 | K143185 | 000 |
| 00816305020038 | K143185 | 000 |
| 00816305020021 | K143185 | 000 |
| 00816305020014 | K143185 | 000 |
| 00816305020007 | K143185 | 000 |
| 00816305023756 | K143185 | 000 |
| 00816305023701 | K143185 | 000 |
| 00816305020076 | K143185 | 000 |
| 00816305020083 | K143185 | 000 |
| 00816305020090 | K143185 | 000 |
| 00816305023329 | K143185 | 000 |
| 00816305023312 | K143185 | 000 |
| 00816305023305 | K143185 | 000 |
| 00816305023299 | K143185 | 000 |
| 00816305021646 | K143185 | 000 |
| 00816305021639 | K143185 | 000 |
| 00816305021622 | K143185 | 000 |
| 00816305021615 | K143185 | 000 |
| 00816305021608 | K143185 | 000 |
| 00816305024524 | K143185 | 000 |