The following data is part of a premarket notification filed by Grace Medical, Inc. with the FDA for Grace Dynamic Torp.
| Device ID | K091187 |
| 510k Number | K091187 |
| Device Name: | GRACE DYNAMIC TORP |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | Grace Medical, Inc. 8500 WOLF LAKE DR., STE. 110 Memphis, TN 38133 |
| Contact | Jeff Cobb |
| Correspondent | Jeff Cobb Grace Medical, Inc. 8500 WOLF LAKE DR., STE. 110 Memphis, TN 38133 |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2009-09-14 |
| Summary: | summary |