510(k) K983869

DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH by Caltech Industries, Inc. — Product Code LRJ

K983869 is an FDA 510(k) premarket notification submitted by Caltech Industries, Inc. for the device "DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH". The FDA issued a decision of Substantially Equivalent on November 30, 1998. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. Caltech Industries, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1998
Date Received
November 2, 1998
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