FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH

K Number: K983869 · Decision Nov 30, 1998
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
72
Applicant Total
5
Review Days
28

Basic Information

Device Name
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
K Number
K983869
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.6890
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
CALTECH INDUSTRIES, INC.
Date Received
November 2, 1998
Decision Date
November 30, 1998
Product Code
LRJ
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LRJ Disinfectant, Medical Devices

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K Number Device Name
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K952336 DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH
K951512 PRECISE HOSPITAL FOAM CLEANER DISINFECTANT