The following data is part of a premarket notification filed by C Change Surgical Llc with the FDA for Intratemp Solution Warmer.
| Device ID | K083417 |
| 510k Number | K083417 |
| Device Name: | INTRATEMP SOLUTION WARMER |
| Classification | Warmer, Irrigation Solution |
| Applicant | C CHANGE SURGICAL LLC 101 NORTH CHESTNUT STREET SUITE 301 Winston-salem, NC 27101 |
| Contact | Patrick Kammer |
| Correspondent | Patrick Kammer C CHANGE SURGICAL LLC 101 NORTH CHESTNUT STREET SUITE 301 Winston-salem, NC 27101 |
| Product Code | LHC |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-18 |
| Decision Date | 2009-01-13 |