The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Aegis I.v. Strips.
| Device ID | K812080 |
| 510k Number | K812080 |
| Device Name: | AEGIS I.V. STRIPS |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | WARNER-LAMBERT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-22 |
| Decision Date | 1981-08-03 |