The following data is part of a premarket notification filed by Smisson-cartledge Biomedical Llc with the FDA for Thermacor 1200 Disposable Sets For The Thermacor 1200 Rapid Thermal Infusion System.
| Device ID | K202461 |
| 510k Number | K202461 |
| Device Name: | ThermaCor 1200 Disposable Sets For The ThermaCor 1200 Rapid Thermal Infusion System |
| Classification | Accessories, Pump, Infusion |
| Applicant | Smisson-Cartledge Biomedical LLC 487 Cherry Street - Third Street Tower Macon, GA 31201 |
| Contact | Calder Clay III |
| Correspondent | Julie Stephens Regulatory Resources Group, Inc. 111 Laurel Ridge Dr Alpharetta, GA 30004 |
| Product Code | MRZ |
| Subsequent Product Code | FRN |
| Subsequent Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-27 |
| Decision Date | 2022-08-12 |