The following data is part of a premarket notification filed by Megaplast, Inc. with the FDA for Open Heart Tray (custom Designed).
| Device ID | K822158 |
| 510k Number | K822158 |
| Device Name: | OPEN HEART TRAY (CUSTOM DESIGNED) |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | MEGAPLAST, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-23 |
| Decision Date | 1982-10-13 |