FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUFFALO FILTER REPLACEMENT FILTER #BST300UL
K Number: K930062
·
Decision Nov 30, 1993
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
74
Applicant Total
22
Review Days
328
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Basic Information
- Device Name
- BUFFALO FILTER REPLACEMENT FILTER #BST300UL
- K Number
- K930062
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Buffalo Filter Co., Inc.
- Date Received
- January 6, 1993
- Decision Date
- November 30, 1993
- Product Code
- FYD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Buffalo Filter Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K131402 | VISICLEAR SMOKE EVACUATION SYSTEM | Mar 3, 2014 | Substantially Equivalent |
| K000904 | PENADAPT 10 | Jun 8, 2000 | Substantially Equivalent |
| K983298 | BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF | Aug 16, 1999 | Substantially Equivalent |
| K983364 | BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 | Aug 11, 1999 | Substantially Equivalent |
| K983333 | BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 | Aug 11, 1999 | Substantially Equivalent |
| K943226 | BUFFALO FILTER REPLACEMENT FILTER #BSPF030 | Jul 10, 1995 | Substantially Equivalent |
| K943227 | BUFFALO FILTER REPLACEMENT FILTER #BSUCF03 | Jul 7, 1995 | Substantially Equivalent |
| K930067 | BUFFALO FILTER SURGICAL MASK | Nov 30, 1993 | Substantially Equivalent |
| K930058 | BUFFALO FILTER REPLACEMENT FILTER #BPTU100 | Nov 30, 1993 | Substantially Equivalent |
| K930063 | BUFFALO FILTER REPLACEMENT FILTER #BCULPA | Nov 12, 1993 | Substantially Equivalent |