510(k) K930060

BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO by Buffalo Filter Co., Inc. — Product Code FYD

K930060 is an FDA 510(k) premarket notification submitted by Buffalo Filter Co., Inc. for the device "BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO". The FDA issued a decision of Substantially Equivalent on November 12, 1993. 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
November 12, 1993
Date Received
January 6, 1993
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