510(k) K983333

BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 by Buffalo Filter Co., Inc. — Product Code FYD

K983333 is an FDA 510(k) premarket notification submitted by Buffalo Filter Co., Inc. for the device "BUFFALO FILTER VIROSAFE HRF- #VSHRFO1". The FDA issued a decision of Substantially Equivalent on August 11, 1999. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Buffalo Filter Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1999
Date Received
September 23, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type