The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Paparell Type 2, Biolite Coated Sili-.
| Device ID | K800728 |
| 510k Number | K800728 |
| Device Name: | PAPARELL TYPE 2, BIOLITE COATED SILI- |
| Classification | Tube, Tympanostomy |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-01 |
| Decision Date | 1980-04-16 |