The following data is part of a premarket notification filed by Medical Products, Llc with the FDA for Theraflow Single Lumen And Theraflow Dual Lumen.
| Device ID | K131023 |
| 510k Number | K131023 |
| Device Name: | THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN |
| Classification | Conserver, Oxygen |
| Applicant | MEDICAL PRODUCTS, LLC 7437 OAKLANDON RD. Indianapolis, IN 46236 |
| Contact | David Mcgill |
| Correspondent | David Mcgill MEDICAL PRODUCTS, LLC 7437 OAKLANDON RD. Indianapolis, IN 46236 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-12 |
| Decision Date | 2013-10-11 |