The following data is part of a premarket notification filed by Ossur Americas Inc with the FDA for Dvtcare Ca5.
| Device ID | K130174 |
| 510k Number | K130174 |
| Device Name: | DVTCARE CA5 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | OSSUR AMERICAS INC 481 PETTIS AVE. Ada, MI 49301 |
| Contact | John Lindahl |
| Correspondent | John Lindahl OSSUR AMERICAS INC 481 PETTIS AVE. Ada, MI 49301 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-24 |
| Decision Date | 2013-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05690977445239 | K130174 | 000 |
| 05690977400863 | K130174 | 000 |
| 05690977382848 | K130174 | 000 |
| 05690977369344 | K130174 | 000 |
| 05690977369283 | K130174 | 000 |
| 05690977369269 | K130174 | 000 |
| 05690977352957 | K130174 | 000 |