The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Attic Defect Plate.
| Device ID | K921433 |
| 510k Number | K921433 |
| Device Name: | ATTIC DEFECT PLATE |
| Classification | Mold, Middle-ear |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Thomas Craig |
| Correspondent | Thomas Craig SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | ETC |
| CFR Regulation Number | 874.3430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-25 |
| Decision Date | 1993-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925012301 | K921433 | 000 |
| 00821925012295 | K921433 | 000 |
| 00821925012288 | K921433 | 000 |