The following data is part of a premarket notification filed by Buffalo Filter Co., Inc. with the FDA for Buffalo Filter Virosafe Hrf- #vshrfo1.
| Device ID | K983333 |
| 510k Number | K983333 |
| Device Name: | BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | BUFFALO FILTER CO., INC. 6000 N. BAILEY AVE, SUITE 9 Buffalo, NY 14226 |
| Contact | Clinton R Holland Jr |
| Correspondent | Clinton R Holland Jr BUFFALO FILTER CO., INC. 6000 N. BAILEY AVE, 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 | 1998-09-23 |
| Decision Date | 1999-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851136002867 | K983333 | 000 |
| 00841494106799 | K983333 | 000 |
| 00841494104856 | K983333 | 000 |
| 00841494104849 | K983333 | 000 |