The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Silicone Tympanostomy Tubes.
| Device ID | K932166 |
| 510k Number | K932166 |
| Device Name: | SILICONE TYMPANOSTOMY TUBES |
| Classification | Tube, Tympanostomy |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Jeff Cobb |
| Correspondent | Jeff Cobb SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-04 |
| Decision Date | 1993-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925028487 | K932166 | 000 |
| 00821925026834 | K932166 | 000 |
| 00821925026889 | K932166 | 000 |
| 00821925026841 | K932166 | 000 |
| 00821925026858 | K932166 | 000 |
| 00821925026872 | K932166 | 000 |
| 00821925026865 | K932166 | 000 |
| 00821925026629 | K932166 | 000 |
| 00821925021396 | K932166 | 000 |
| 00821925021006 | K932166 | 000 |
| 00821925026827 | K932166 | 000 |
| 00821925028463 | K932166 | 000 |
| 00821925025400 | K932166 | 000 |
| 00821925039728 | K932166 | 000 |
| 00821925026568 | K932166 | 000 |
| 00821925039681 | K932166 | 000 |
| 00821925039674 | K932166 | 000 |
| 00821925021624 | K932166 | 000 |
| 00821925021501 | K932166 | 000 |
| 00821925025417 | K932166 | 000 |
| 00821925026117 | K932166 | 000 |
| 00821925028708 | K932166 | 000 |
| 00821925030718 | K932166 | 000 |