The following data is part of a premarket notification filed by Harding Medical Devices with the FDA for Harding Sternal Shield.
| Device ID | K911407 |
| 510k Number | K911407 |
| Device Name: | HARDING STERNAL SHIELD |
| Classification | Protector, Wound, Plastic |
| Applicant | HARDING MEDICAL DEVICES P.O. BOX 10151 Greensboro, NC 27404 |
| Contact | Bridget Harding |
| Correspondent | Bridget Harding HARDING MEDICAL DEVICES P.O. BOX 10151 Greensboro, NC 27404 |
| Product Code | EYF |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-29 |
| Decision Date | 1991-07-05 |