510(k) K954292

Q5. 5-5.5NPB-2.5HW by Central Solutions, Inc. — Product Code LRJ

K954292 is an FDA 510(k) premarket notification submitted by Central Solutions, Inc. for the device "Q5. 5-5.5NPB-2.5HW". The FDA issued a decision of Substantially Equivalent on September 27, 1995. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. Central Solutions, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1995
Date Received
September 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Disinfectant, Medical Devices
Device Class
Class I
Regulation Number
880.6890
Review Panel
HO
Submission Type