The following data is part of a premarket notification filed by Buffalo Filter Co., Inc. with the FDA for Buffalo Filter Replacement Filter #bcr0043.
| Device ID | K930065 |
| 510k Number | K930065 |
| Device Name: | BUFFALO FILTER REPLACEMENT FILTER #BCR0043 |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | BUFFALO FILTER CO., INC. 8388 BRIDLEWOOD DR. E. Amherst, NY 14051 |
| Contact | Clinton R Holland |
| Correspondent | Clinton R Holland BUFFALO FILTER CO., INC. 8388 BRIDLEWOOD DR. E. Amherst, NY 14051 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-06 |
| Decision Date | 1993-11-12 |