The following data is part of a premarket notification filed by Edwards Laboratories with the FDA for Disposable Holder For Bioprosthesis.
| Device ID | K790022 |
| 510k Number | K790022 |
| Device Name: | DISPOSABLE HOLDER FOR BIOPROSTHESIS |
| Classification | Holder, Heart-valve, Prosthesis |
| Applicant | EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTJ |
| CFR Regulation Number | 870.3935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-03 |
| Decision Date | 1979-01-15 |