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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 K982985
Device Name CITREX HOSPITAL SPRAY DISINFECTANT
Applicant
Caltech Industries, Inc.
2420 Schuette Dr.
Midland,  MI  48642
Applicant Contact DONALD JOHNSON
Correspondent
Caltech Industries, Inc.
2420 Schuette Dr.
Midland,  MI  48642
Correspondent Contact DONALD JOHNSON
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received08/26/1998
Decision Date 11/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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