The following data is part of a premarket notification filed by Intl. Hospital Products, Inc. with the FDA for Redo Central Venous Catheter-neonate.
| Device ID | K841443 |
| 510k Number | K841443 |
| Device Name: | REDO CENTRAL VENOUS CATHETER-NEONATE |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | INTL. HOSPITAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-06 |
| Decision Date | 1984-07-27 |