The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Fogarty Flexible Calibrator.
| Device ID | K810894 |
| 510k Number | K810894 |
| Device Name: | FOGARTY FLEXIBLE CALIBRATOR |
| Classification | Dilator, Vessel, Surgical |
| Applicant | AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWP |
| CFR Regulation Number | 870.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-03 |
| Decision Date | 1981-05-15 |