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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 K992661
Device Name CONTROL III ELITE
Applicant
MARIL PRODUCTS, INC.
320 WEST 6TH ST.
TUSTIN,  CA  92780
Applicant Contact ANNE R WHITEHAIR
Correspondent
MARIL PRODUCTS, INC.
320 WEST 6TH ST.
TUSTIN,  CA  92780
Correspondent Contact ANNE R WHITEHAIR
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received08/09/1999
Decision Date 09/14/1999
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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