The following data is part of a premarket notification filed by Smisson-cartledge Biomedical Llc with the FDA for Smisson-cartledge Thermal Infusion System, Model Tis-1200.
| Device ID | K052055 |
| 510k Number | K052055 |
| Device Name: | SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | SMISSON-CARTLEDGE BIOMEDICAL LLC 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Contact | Julie Stephens |
| Correspondent | Julie Stephens SMISSON-CARTLEDGE BIOMEDICAL LLC 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-29 |
| Decision Date | 2006-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857893006219 | K052055 | 000 |
| 10857893006070 | K052055 | 000 |
| 10857893006063 | K052055 | 000 |
| 10857893006056 | K052055 | 000 |
| 00857893006042 | K052055 | 000 |
| 00857893006035 | K052055 | 000 |
| 00857893006028 | K052055 | 000 |
| 00857893006011 | K052055 | 000 |
| 00857893006004 | K052055 | 000 |
| 00857893006080 | K052055 | 000 |
| 20857893006091 | K052055 | 000 |
| 00857893006196 | K052055 | 000 |
| 00857893006189 | K052055 | 000 |
| 10857893006155 | K052055 | 000 |
| 00857893006141 | K052055 | 000 |
| 00857893006134 | K052055 | 000 |
| 20857893006121 | K052055 | 000 |
| 10857893006117 | K052055 | 000 |
| 20857893006107 | K052055 | 000 |
| 00857893006226 | K052055 | 000 |