The following data is part of a premarket notification filed by Buffalo Filter Co., Inc. with the FDA for Penadapt 10.
| Device ID | K000904 |
| 510k Number | K000904 |
| Device Name: | PENADAPT 10 |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | BUFFALO FILTER CO., INC. 595 COMMERCE DR. Buffalo, NY 14228 |
| Contact | Kathleen H Selover |
| Correspondent | Kathleen H Selover BUFFALO FILTER CO., INC. 595 COMMERCE DR. Buffalo, NY 14228 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-21 |
| Decision Date | 2000-06-08 |