The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Iv Sets.
| Device ID | K811107 |
| 510k Number | K811107 |
| Device Name: | IV SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | CRITIKON COMPANY,LLC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-23 |
| Decision Date | 1981-06-12 |