510(k) K943226

BUFFALO FILTER REPLACEMENT FILTER #BSPF030 by Buffalo Filter Co., Inc. — Product Code FYD

K943226 is an FDA 510(k) premarket notification submitted by Buffalo Filter Co., Inc. for the device "BUFFALO FILTER REPLACEMENT FILTER #BSPF030". The FDA issued a decision of Substantially Equivalent on July 10, 1995. 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
July 10, 1995
Date Received
July 6, 1994
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