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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 K904581
Device Name SPORICIDIN BRAND DISINFECTANT SOLUTION
Applicant
Sporicidin Intl.
5901 Montrose Rd.
Rockville,  MD  20852
Applicant Contact EDWARD G FAETH
Correspondent
Sporicidin Intl.
5901 Montrose Rd.
Rockville,  MD  20852
Correspondent Contact EDWARD G FAETH
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received10/09/1990
Decision Date 05/18/1992
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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