The following data is part of a premarket notification filed by Buffalo Filter Co., Inc. with the FDA for Buffalo Filter Virosafe 18 Filter-catalog #vso1801.
| Device ID | K983364 |
| 510k Number | K983364 |
| Device Name: | BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 |
| 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 | 1998-09-24 |
| Decision Date | 1999-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815198011205 | K983364 | 000 |
| 10607151063181 | K983364 | 000 |
| 00840319734537 | K983364 | 000 |
| 00840319734520 | K983364 | 000 |