The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Ventilation Tubes.
| Device ID | K960477 |
| 510k Number | K960477 |
| Device Name: | VENTILATION TUBES |
| Classification | Tube, Tympanostomy |
| Applicant | SMITH & NEPHEW, INC. 555 13TH ST., N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein SMITH & NEPHEW, INC. 555 13TH ST., N.W. Washington, DC 20004 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-01 |
| Decision Date | 1996-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925028692 | K960477 | 000 |
| 00821925027046 | K960477 | 000 |
| 00821925026193 | K960477 | 000 |
| 00821925026988 | K960477 | 000 |
| 00821925026995 | K960477 | 000 |
| 00821925026940 | K960477 | 000 |
| 00821925026537 | K960477 | 000 |
| 00821925027015 | K960477 | 000 |
| 00821925027053 | K960477 | 000 |
| 00821925026575 | K960477 | 000 |
| 00821925026551 | K960477 | 000 |
| 00821925026544 | K960477 | 000 |
| 00821925026520 | K960477 | 000 |
| 00821925027060 | K960477 | 000 |
| 00821925021655 | K960477 | 000 |
| 00821925027022 | K960477 | 000 |
| 00821925026209 | K960477 | 000 |
| 00821925027077 | K960477 | 000 |
| 00821925027008 | K960477 | 000 |
| 00821925026971 | K960477 | 000 |
| 00821925026964 | K960477 | 000 |