510(k) K951162

PHENO-CEN GERMICIDAL DETERGENT by Central Solutions, Inc. — Product Code LRJ

K951162 is an FDA 510(k) premarket notification submitted by Central Solutions, Inc. for the device "PHENO-CEN GERMICIDAL DETERGENT". The FDA issued a decision of Substantially Equivalent on July 11, 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
July 11, 1995
Date Received
March 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