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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 K983194
Device Name SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)
Applicant
Sporicidin Intl.
5901 Montrose Rd.
Rockville,  MD  20852
Applicant Contact HAROLD E PLANK
Correspondent
Sporicidin Intl.
5901 Montrose Rd.
Rockville,  MD  20852
Correspondent Contact HAROLD E PLANK
Regulation Number880.6885
Classification Product Code
MED  
Date Received09/11/1998
Decision Date 03/05/1999
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
Predetermined Change
Control Plan Authorized		 No
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