FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801

K Number: K983364 · Decision Aug 11, 1999
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
74
Applicant Total
22
Review Days
321

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Basic Information

Device Name
BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
K Number
K983364
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
September 24, 1998
Decision Date
August 11, 1999
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
FYD Apparatus, Exhaust, Surgical

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Other Clearances by Buffalo Filter Co., Inc.

K Number Device Name
K131402 VISICLEAR SMOKE EVACUATION SYSTEM
K000904 PENADAPT 10
K983298 BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
K983333 BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
K943226 BUFFALO FILTER REPLACEMENT FILTER #BSPF030
K943227 BUFFALO FILTER REPLACEMENT FILTER #BSUCF03
K930067 BUFFALO FILTER SURGICAL MASK
K930058 BUFFALO FILTER REPLACEMENT FILTER #BPTU100
K930062 BUFFALO FILTER REPLACEMENT FILTER #BST300UL
K930063 BUFFALO FILTER REPLACEMENT FILTER #BCULPA
Search all 22 clearances from Buffalo Filter Co., Inc. →