510(k) K902167

CONTAIN(TM) LASER PLUME FILTER by Arbor Technologies, Inc. — Product Code JDY

K902167 is an FDA 510(k) premarket notification submitted by Arbor Technologies, Inc. for the device "CONTAIN(TM) LASER PLUME FILTER". The FDA issued a decision of Substantially Equivalent on January 4, 1991. The device falls under product code JDY (Evacuator, Vapor, Cement Monomer), a Class I device regulated under 21 CFR 888.4220. Arbor Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1991
Date Received
May 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Evacuator, Vapor, Cement Monomer
Device Class
Class I
Regulation Number
888.4220
Review Panel
OR
Submission Type