The following data is part of a premarket notification filed by Tyco Healthcare/kendall with the FDA for Scd Express Portable Compression System.
| Device ID | K040511 |
| 510k Number | K040511 |
| Device Name: | SCD EXPRESS PORTABLE COMPRESSION SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | TYCO HEALTHCARE/KENDALL 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Bridget Gardner |
| Correspondent | Bridget Gardner TYCO HEALTHCARE/KENDALL 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-27 |
| Decision Date | 2004-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521003146 | K040511 | 000 |
| 10884521003163 | K040511 | 000 |
| 10884521082601 | K040511 | 000 |