The following data is part of a premarket notification filed by Grace Medical, Inc. with the FDA for Partial & Total Ossicular Replacement Prosthesis.
| Device ID | K963752 |
| 510k Number | K963752 |
| Device Name: | PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | Grace Medical, Inc. 8624 NORTH LAKE COVE Arlington, TN 38002 |
| Contact | Anthony D Prescott |
| Correspondent | Anthony D Prescott Grace Medical, Inc. 8624 NORTH LAKE COVE Arlington, TN 38002 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-18 |
| Decision Date | 1996-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844505000215 | K963752 | 000 |
| 00844505000093 | K963752 | 000 |
| 00844505000086 | K963752 | 000 |
| 00844505000079 | K963752 | 000 |
| 00844505000062 | K963752 | 000 |
| 00844505000055 | K963752 | 000 |
| 00844505000048 | K963752 | 000 |
| 00844505000031 | K963752 | 000 |
| 00844505000024 | K963752 | 000 |
| 00844505000109 | K963752 | 000 |
| 00844505000116 | K963752 | 000 |
| 00844505000123 | K963752 | 000 |
| 00844505000208 | K963752 | 000 |
| 00844505000192 | K963752 | 000 |
| 00844505000185 | K963752 | 000 |
| 00844505000178 | K963752 | 000 |
| 00844505000161 | K963752 | 000 |
| 00844505000154 | K963752 | 000 |
| 00844505000147 | K963752 | 000 |
| 00844505000130 | K963752 | 000 |
| 00844505000017 | K963752 | 000 |