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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 K964828
Device Name VIREX II 128 GERMICIDAL CLEANER AND DEODORANT
Applicant
S.C. Johnson & Son, Inc.
1525 Howe St.
Racine,  WI  53403
Applicant Contact ROBERT B O'BRIEN
Correspondent
S.C. Johnson & Son, Inc.
1525 Howe St.
Racine,  WI  53403
Correspondent Contact ROBERT B O'BRIEN
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received12/02/1996
Decision Date 12/19/1996
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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