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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Purifier, Water, Ultraviolet, Medical
510(k) Number K813045
Device Name AQUANOMICS, #SP36SF
Applicant
Cooper-Hewitt Electric Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cooper-Hewitt Electric Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6710
Classification Product Code
KMG  
Date Received10/28/1981
Decision Date 12/02/1981
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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