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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 K990703
Device Name SPOROX II STERILIZING & DISINFECTING SOLUTION
Applicant
Reckitt Benckiser, Inc.
1655 Valley Rd.
Wayne,  NJ  07474
Applicant Contact SEAN MCNEAR
Correspondent
Reckitt Benckiser, Inc.
1655 Valley Rd.
Wayne,  NJ  07474
Correspondent Contact SEAN MCNEAR
Regulation Number880.6885
Classification Product Code
MED  
Date Received03/04/1999
Decision Date 03/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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