The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Intravenous Catheters Modifications.
| Device ID | K921295 |
| 510k Number | K921295 |
| Device Name: | INTRAVENOUS CATHETERS MODIFICATIONS |
| Classification | Dislodger, Stone, Flexible |
| Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Contact | John Matson |
| Correspondent | John Matson CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Product Code | FGO |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-12 |
| Decision Date | 1993-05-17 |