The following data is part of a premarket notification filed by Buffalo Filter Co., Inc. with the FDA for Buffalo Filter Replacement Filter #bspf030.
| Device ID | K943226 |
| 510k Number | K943226 |
| Device Name: | BUFFALO FILTER REPLACEMENT FILTER #BSPF030 |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | BUFFALO FILTER CO., INC. 6000 NORTH BAILEY AVENUE, SUITE 9 Buffalo, NY 14226 |
| Contact | Clinton R Holland |
| Correspondent | Clinton R Holland BUFFALO FILTER CO., INC. 6000 NORTH BAILEY AVENUE, SUITE 9 Buffalo, NY 14226 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-06 |
| Decision Date | 1995-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851136002751 | K943226 | 000 |
| 10851136002706 | K943226 | 000 |
| 00851136002648 | K943226 | 000 |
| 10851136002577 | K943226 | 000 |
| 20851136002451 | K943226 | 000 |
| 20851136002130 | K943226 | 000 |