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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K012889
Device Name BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
Applicant
PASCAL CO., INC.
1001 G STREET, N.W.
SUITE 500 WEST
WASHINGTON,  DC  20001
Applicant Contact DAVID R JOY
Correspondent
PASCAL CO., INC.
1001 G STREET, N.W.
SUITE 500 WEST
WASHINGTON,  DC  20001
Correspondent Contact DAVID R JOY
Regulation Number880.6885
Classification Product Code
MED  
Date Received08/28/2001
Decision Date 05/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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