The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocesses Umbilical Cable.
| Device ID | K221854 |
| 510k Number | K221854 |
| Device Name: | Reprocesses Umbilical Cable |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | Innovative Health, LLC. 1435 North Hayden Road Suite 100 Scottsdale, AZ 85257 |
| Contact | Rick Ferreira |
| Correspondent | Meerna Muradvich Innovative Health, LLC. 1435 North Hayden Road Suite 100 Scottsdale, AZ 85257 |
| Product Code | NLH |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-27 |
| Decision Date | 2022-08-06 |