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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 K960582
Device Name ASCEND GENERAL PURPOSE DISINFECTANT
Applicant
HUNTINGTON LABORATORIES, INC.
970 E. TIPTON ST.
HUNTINGTON,  IN  46750
Applicant Contact SALLY HAYES
Correspondent
HUNTINGTON LABORATORIES, INC.
970 E. TIPTON ST.
HUNTINGTON,  IN  46750
Correspondent Contact SALLY HAYES
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received02/12/1996
Decision Date 03/12/1996
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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