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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 K003087
Device Name MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
Applicant
Sporicidin Intl.
121 Congressional Ln.
Rockville,  MD  20852
Applicant Contact HAROLD E PLANK
Correspondent
Sporicidin Intl.
121 Congressional Ln.
Rockville,  MD  20852
Correspondent Contact HAROLD E PLANK
Regulation Number880.6885
Classification Product Code
MED  
Date Received09/27/2000
Decision Date 11/07/2000
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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