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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 K934150
Device Name BIOCIDE CLEANER/DISINFECTANT
Applicant
Juan Sierra
650 S. Taylor Ave.
Suite 20
Louisville,  CO  80027
Applicant Contact BRAHMA D SHARMA
Correspondent
Juan Sierra
650 S. Taylor Ave.
Suite 20
Louisville,  CO  80027
Correspondent Contact BRAHMA D SHARMA
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received08/25/1993
Decision Date 12/06/1995
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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