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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Disinfectant, Medical Devices
510(k) Number K952405
Device Name CITRACE HOSPITAL GERMICIDAL DEODORIZER
Applicant
Caltech Industries, Inc.
2420 Schuette Dr.
Midland,  MI  48642
Applicant Contact DON JOHNSON
Correspondent
Caltech Industries, Inc.
2420 Schuette Dr.
Midland,  MI  48642
Correspondent Contact DON JOHNSON
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received05/22/1995
Decision Date 08/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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