The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Activent Antimicrobial Ventilation Tubes.
| Device ID | K961873 |
| 510k Number | K961873 |
| Device Name: | ACTIVENT ANTIMICROBIAL VENTILATION TUBES |
| Classification | Tube, Tympanostomy |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | David Timlin |
| Correspondent | David Timlin XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-15 |
| Decision Date | 1996-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20681490075910 | K961873 | 000 |
| 20681490030308 | K961873 | 000 |
| 20681490030520 | K961873 | 000 |
| 20681490030780 | K961873 | 000 |
| 20681490030841 | K961873 | 000 |
| 20681490030865 | K961873 | 000 |
| 20681490030889 | K961873 | 000 |
| 20681490030933 | K961873 | 000 |
| 20681490030940 | K961873 | 000 |
| 20681490030964 | K961873 | 000 |
| 20681490030971 | K961873 | 000 |
| 20681490030988 | K961873 | 000 |
| 20681490030995 | K961873 | 000 |
| 20681490030292 | K961873 | 000 |