Buffalo Filter Replacement Filter #BCR0030
by Buffalo Filter Co., Inc. 510(k)
Active
510(k) K930064
Overview
This device is an apparatus for exhaust in surgical settings, as defined by its device type and nomenclature. It is a replacement filter designed for use with surgical exhaust systems.
The Buffalo Filter Replacement Filter #BCR0030 is supplied non-sterile and is intended for single use. It is used in general and plastic surgery environments, and its regulatory authorization is based on FDA 510(k) clearance under product code FYD and regulation number 878.5070.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930064 | Date12 Nov 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FYD
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.5070
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent