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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 K945227
Device Name OCIDE HOSPITAL CLEANER-DISINFECTANT
Applicant
Clariant Corporation
3411 Silverside Rd.
104 Hagley Bldg.
Wilmington,  DE  19810
Applicant Contact R L SCHAUER
Correspondent
Clariant Corporation
3411 Silverside Rd.
104 Hagley Bldg.
Wilmington,  DE  19810
Correspondent Contact R L SCHAUER
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received10/26/1994
Decision Date 03/23/1995
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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